## Summary of Data & Information Contained in the PMA

+-------------+--------------------------------------------------------+
| ###         | > This summary contains the following information:     |
| ## Summary  |                                                        |
| Information | 1.  General Information                                |
|             |                                                        |
|             | 2.  Indications for Use                                |
|             |                                                        |
|             | 3.  Contraindications                                  |
|             |                                                        |
|             | 4.  Warnings                                           |
|             |                                                        |
|             | 5.  Precautions                                        |
|             |                                                        |
|             | 6.  Device Description                                 |
|             |                                                        |
|             | 7.  Alternative Practices and Procedures               |
|             |                                                        |
|             | 8.  Marketing History                                  |
|             |                                                        |
|             | 9.  Adverse Events                                     |
|             |                                                        |
|             | 10. Summary of Studies                                 |
|             |                                                        |
|             |     a.  Nonclinical Studies                            |
|             |                                                        |
|             |     b.  Clinical Investigations                        |
|             |                                                        |
|             | 11. Conclusions Drawn from Studies                     |
|             |                                                        |
|             | 12. Panel Recommendation                               |
|             |                                                        |
|             | 13. CDRH Decision                                      |
|             |                                                        |
|             | 14. Approval Specification                             |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 1.    | +-------------------+------------------------------+   |
|             | | > Device Generic  | > Advanced Mobility System   |   |
| ####        | | > Name            |                              |   |
| # General I | +-------------------+------------------------------+   |
| nformation  | | > Device Trade    | > INDEPENDENCE™ iBOT™ 3000   |   |
|             | | > Name            | > Mobility System            |   |
|             | +-------------------+------------------------------+   |
|             | | > Applicant's     | > Independence Technology,   |   |
|             | | > Name and        | > LLC.                       |   |
|             | | > Address         | >                            |   |
|             | |                   | > 45 Technology Drive        |   |
|             | |                   | >                            |   |
|             | |                   | > Warren, NJ 07059           |   |
|             | +-------------------+------------------------------+   |
|             | | > PMA Number      | > P020033                    |   |
|             | +-------------------+------------------------------+   |
|             | | > Date of Panel   | > 11/20/02                   |   |
|             | | > Recommendation  |                              |   |
|             | +-------------------+------------------------------+   |
|             | | > Date of Notice  | > TBD                        |   |
|             | | > of Approval to  |                              |   |
|             | | > Applicant       |                              |   |
|             | +-------------------+------------------------------+   |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| #####       | > The INDEPENDENCE™ iBOT™ 3000 Mobility System is a    |
| 2. Indicati | > powered mobility device for individuals who have     |
| ons For Use | > mobility impairments and the use of at least one     |
|             | > upper extremity. The device is intended to provide   |
|             | > indoor and outdoor mobility in confined spaces, at   |
|             | > an elevated height, climb curbs, ascend/descend      |
|             | > stairs, traverse obstacles, travel over a wide       |
|             | > variety of terrain and negotiate uneven/inclined     |
|             | > surfaces.                                            |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| **3.**      | > Contraindications are the Inclusion/Exclusion        |
|             | > criteria presented in the product labeling.          |
| **Contra-in |                                                        |
| dications** |                                                        |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 4.    | -   Fracture risks for persons with severe osteopenia, |
|             |     > osteogenesis imperfecta and spinal metastatic    |
| *           |     > bone cancer.                                     |
| *Warnings** |                                                        |
|             | -   Additional Warnings regarding proper use are       |
|             |     > presented throughout the product labeling.       |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 5.    | -   Complete training                                  |
|             |                                                        |
| **Pr        | -   Read product labeling thoroughly. Additional       |
| ecautions** |     > Precautions are presented throughout product     |
|             |     > labeling.                                        |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 6.    | The INDEPENDENCE™ iBOT™ 3000 Mobility System is a      |
|             | battery operated advanced mobility system designed for |
| ##          | both indoor and outdoor use.                           |
| ### Device  |                                                        |
| Description | ![](media/image1.jpeg){width="2.15in"                  |
|             | height="2.6547244094488187in"}The INDEPENDENCE™ iBOT™  |
|             | 3000 Mobility System can be divided into two essential |
|             | parts -- a Seating System and a Power Base. The        |
|             | seating system includes all the components designed to |
|             | support a person in a seated position. The power base  |
|             | includes all the components that provide mobility --   |
|             | the wheels, batteries, motors and computers.           |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### ![](m | The front view of the INDEPENDENCE™ iBOT™ 3000         |
| edia/image2 | Mobility System:                                       |
| .jpeg){widt |                                                        |
| h="2.430708 |                                                        |
| 661417323in |                                                        |
| " height="3 |                                                        |
| .4362204724 |                                                        |
| 40945in"}6. |                                                        |
|             |                                                        |
| ##### Devi  |                                                        |
| ce Descript |                                                        |
| ion (cont.) |                                                        |
+-------------+--------------------------------------------------------+
| #####       |                                                        |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### ![](  | The rear view of the INDEPENDENCE™ iBOT™ 3000 Mobility |
| media/image | System:                                                |
| 3.jpeg){wid |                                                        |
| th="2.05in" | The device provides up to five operating functions:    |
|  height="2. | Standard, 4-Wheel, Balance, Stair and Remote. The      |
| 74027777777 | purposes of these functions are to provide:            |
| 77776in"}6. |                                                        |
|             | -   Mobility on smooth surfaces and inclines at home,  |
| ##### Devi  |     work, and in other environments. (Standard         |
| ce Descript |     Function)                                          |
| ion (cont.) |                                                        |
|             | -   Movement across obstacles, uneven terrain, curbs,  |
|             |     grass, gravel, and other soft surfaces. (4-Wheel   |
|             |     Function)                                          |
|             |                                                        |
|             | -   Mobility in a seated position at an elevated       |
|             |     height. (Balance Function)                         |
|             |                                                        |
|             | -   Ascent and descent of stairs with or without       |
|             |     assistance. (Stair Function)                       |
|             |                                                        |
|             | -   Mobility and transportation of the product while   |
|             |     unoccupied. (Remote Function)                      |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 6.    | > The INDEPENDENCE™ iBOT™3000 Mobility System is able  |
|             | > to perform in each of these operating environments   |
| ##### Devi  | > because it is dynamically stabilized. This dynamic   |
| ce Descript | > stabilization is called the I-Balance™ Technology.   |
| ion (cont.) |                                                        |
|             | The I-BALANCE™ Technology in the INDEPENDENCE™ iBOT™   |
|             | 3000 Mobility System uses a computer system that works |
|             | in conjunction with gyroscopes. When the gyroscopes    |
|             | sense movement, a signal is sent to the computer. The  |
|             | computer processes the information and tells the       |
|             | motors to move the wheels to maintain stability and    |
|             | balance.                                               |
|             |                                                        |
|             | > The I-BALANCE™ Technology maintains balance in the   |
|             | > forward and backward directions. This means the      |
|             | > INDEPENDENCE™ iBOT™ 3000 Mobility System will keep   |
|             | > the seat relatively level when driving straight up   |
|             | > or down curbs or inclines. It does not               |
|             | > electronically maintain lateral or side-to-side      |
|             | > stability.                                           |
|             | >                                                      |
|             | > The INDEPENDENCE™ iBOT™ 3000 Mobility System has     |
|             | > four operating functions that use the I-BALANCE™     |
|             | > Technology: 4‑Wheel, Balance, Stair and Remote. Each |
|             | > function uses the core technology in a slightly      |
|             | > different way.                                       |
|             | >                                                      |
|             | > **[4-Wheel Function]{.underline}**                   |
|             | > ![](media/image4.png){width="1.1402777777777777in"   |
|             | > height="1.417361111111111in"}                        |
|             | >                                                      |
|             | > 4-Wheel Function provides the user with mobility and |
|             | > flexibility in a wide variety of environments.       |
|             | > 4-Wheel Function is the 4-wheel drive of the         |
|             | > INDEPENDENCE™ iBOT™ 3000 Mobility System, enabling   |
|             | > users to traverse inclines up to 8 degrees and over  |
|             | > soft, uneven terrain such as sand, gravel, dirt,     |
|             | > grass, etc. In 4-Wheel Function the device can also  |
|             | > navigate over obstacles up to 4 inches and through   |
|             | > water up to 3 inches deep. In 4-Wheel Function the   |
|             | > I-Balance™ Technology, sensor data and user commands |
|             | > are processed so that the device reacts to changes   |
|             | > in pitch caused by the changes in terrain, external  |
|             | > impacts and other factors. The device uses both      |
|             | > wheel and cluster position to maintain stability.    |
|             | > For example, if the user drives the device up a      |
|             | > curb, the cluster will rotate (in reaction to the    |
|             | > change in pitch) to maintain a level seat as the     |
|             | > wheels drive forward. In this manner stability is    |
|             | > enhanced even during a steep ascent.                 |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 6.    | > **[Balance Function]{.underline}**                   |
|             | > ![](media/image5.png){width="1.1680555555555556in"   |
| ##### Devi  | > height="1.5243055555555556in"}                       |
| ce Descript | >                                                      |
| ion (cont.) | > Balance Function provides mobility at an elevated    |
|             | > height. As the name suggests, in Balance Function    |
|             | > the INDEPENDENCE™ iBOT™ 3000 Mobility System mimics  |
|             | > human balance in that it operates on two points of   |
|             | > contact with the ground. This is accomplished by the |
|             | > combined weight of the device and the user shifting  |
|             | > over the back wheels. The device reacts to this      |
|             | > center of gravity change by transitioning up onto    |
|             | > two wheels. A brake locks the clusters into this     |
|             | > vertical arrangement. In Balance Function the        |
|             | > mobility system maintains stability by driving the   |
|             | > wheels to stay under the user. In Balance Function   |
|             | > the seat height can be raised and lowered to         |
|             | > facilitate the reaching of objects on shelves or     |
|             | > having a "eye-level" conversation with a standing    |
|             | > person. Balance Function is appropriate for firm     |
|             | > surfaces with an incline up to 5 degrees and         |
|             | > obstacles up to ½ inch.                              |
|             | >                                                      |
|             | > **[Stair Function]{.underline}**                     |
|             | > ![](media/image6.png){width="1.5208333333333333in"   |
|             | > height="1.3583333333333334in"}                       |
|             | >                                                      |
|             | > Stair Function enables the user to ascend or descend |
|             | > commonly encountered stairs either by themselves or  |
|             | > with an assistant. Stair climbing is achieved by the |
|             | > rotation of the clusters over the stairs using a     |
|             | > similar closed-loop control algorithm that uses      |
|             | > pitch and sensor data to control the cluster motors. |
|             | > The device strives to keep the center of gravity of  |
|             | > the system over the ground contacting wheels. When a |
|             | > user leans either forward or back (or an assistant   |
|             | > leans the device), shifting the center of gravity,   |
|             | > the device will rotate the clusters in response,     |
|             | > which will result in the device climbing down or up  |
|             | > one stair respectively. The user will climb up or    |
|             | > down a staircase facing down the stairs with the     |
|             | > direction of the weight shift (lean) determining the |
|             | > direction of climbing.                               |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 6.    | The joystick is deactivated in Stair Function to       |
|             | prevent unintentional deflection of the joystick on    |
| ##### Devi  | the stairs. When a landing is reached the user can     |
| ce Descript | transition into 4-Wheel Function and drive away from   |
| ion (cont.) | the stairs. The user/assistant is the input device     |
|             | during stair climbing as they control the rate of      |
|             | climbing and provide stability by holding the stair    |
|             | handrails (user) or the Assist Handle (assistant).     |
|             |                                                        |
|             | > **[Remote Function]{.underline}**                    |
|             | > ![](media/image7.png){width="0.6354166666666666in"   |
|             | > height="0.4166666666666667in"}                       |
|             |                                                        |
|             | Remote Function provides the user with a way to        |
|             | operate the mobility system when not seated in it.     |
|             | Remote Function is useful for maneuvering the device   |
|             | for transfers, parking the device after a transfer,    |
|             | for driving into a vehicle for transport and for other |
|             | purposes. The User Control Panel (UCP) may be removed  |
|             | from its mount on the armrest and operated via a       |
|             | five-foot length retractable cable.                    |
|             |                                                        |
|             | Entry into Remote Function is only allowed when the    |
|             | seat is folded to prevent use of this function when a  |
|             | user is seated in the device. This is because the      |
|             | device was designed to have an empty seat in this      |
|             | function. Since the device does not have to keep a     |
|             | user stable it is able to traverse inclines up to 25   |
|             | degrees (e.g. up a ramp to get into the back of a      |
|             | SUV).                                                  |
|             |                                                        |
|             | While this function is very good for steep inclines it |
|             | is not appropriate for obstacles for a wide variety of |
|             | terrain. Remote Function is appropriate for firm, even |
|             | surfaces with obstacles no great than 1 inch.          |
|             |                                                        |
|             | > **[Standard Function]{.underline}**                  |
|             | > ![](media/image8.png){width="1.0965277777777778in"   |
|             | > height="1.4111111111111112in"}                       |
|             |                                                        |
|             | In Standard Function the INDEPENDENCE™ iBOT™ does not  |
|             | use the I-Balance™ Technology. In this function the    |
|             | mobility system behaves like a current power           |
|             | wheelchair. The seat is at the lowest available        |
|             | position in this function. The casters attached to the |
|             | base of the seat are in contact with the ground and    |
|             | the front drive wheels are raised off the ground. The  |
|             | casters provide good turning performance in this       |
|             | function.                                              |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 6.    | > As with currently marketed power wheelchairs, the    |
|             | > use of casters limits the terrain and obstacle       |
| ##### Devi  | > performance. Standard Function is appropriate for    |
| ce Descript | > relatively firm (e.g. indoor environments,           |
| ion (cont.) | > sidewalks, and pavement) surfaces with up to a 5     |
|             | > degree incline and obstacles up to ½ inch.           |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 7.    | In 1990, the National Institute for Disability and     |
|             | Rehabilitation Research (NIDDR) and the National       |
| **          | Center for Health Statistics (NCHS) conducted a survey |
| Alternative | to estimate the number of people using assistive       |
| Practices   | technology. Of the 13,128,000 people interviewed,      |
| and         | 6,403,000 people, or 48.8% reported that they use      |
| P           | assistive mobility technology (LaPlante, et. al.,      |
| rocedures** | 1992).                                                 |
|             |                                                        |
|             | Furthermore, in an independent discussion of this      |
|             | survey's findings, LaPlante indicates that this        |
|             | population uses 8,487,000 mobility devices,            |
|             | highlighting the fact that a significant number of     |
|             | people use more than one mobility device.              |
|             |                                                        |
|             | A wide variety of mobility devices are identified in   |
|             | the above-mentioned report. In general, mobility       |
|             | devices can be divided into four categories (Sprigle,  |
|             | S. & Lane, J.P., 1995):                                |
|             |                                                        |
|             | -   *balance aids*                                     |
|             |                                                        |
|             | -   *dependent mobility devices*                       |
|             |                                                        |
|             | -   *independent manual mobility devices*              |
|             |                                                        |
|             | ```{=html}                                             |
|             | <!-- -->                                               |
|             | ```                                                    |
|             | -   *independent power mobility devices*               |
|             |                                                        |
|             | > *Balance aids* include canes, crutches, and walkers. |
|             | > These devices provide support and stability during   |
|             | > ambulation. Canes support approximately 25% of a     |
|             | > person's body weight, while walkers are designed to  |
|             | > support all of a person's body weight.               |
|             | >                                                      |
|             | > Overall, balance aids are used by individuals who    |
|             | > have the functional capability to ambulate, but have |
|             | > muscle weakness and incoordination that inhibits     |
|             | > them from ambulating safely without assistance.      |
|             |                                                        |
|             | *Dependent mobility devices* are manual wheelchairs,   |
|             | which are propelled by a person other than the user.   |
|             | These devices are used by individuals for whom         |
|             | independent mobility is not an option, nor a goal.     |
|             | These wheelchairs tend to be the heaviest type of      |
|             | manual wheelchair, weighing between 50 and 70 pounds   |
|             | (Taylor, S.J. & Kreutz, D., 1997). These wheelchairs   |
|             | are most commonly used as transport chairs in          |
|             | hospitals, malls, airports, and other facilities.      |
+-------------+--------------------------------------------------------+

Continued on next page

+-------------+--------------------------------------------------------+
| ##### 7.    | > *Independent manual mobility devices* are            |
|             | > self-propelled wheelchairs that are typically        |
| ##### Alt   | > designed with two large wheels that can be pushed by |
| ernative Pr | > the user. These wheelchairs are lighter in weight    |
| actices and | > than the dependent mobility devices, and are far     |
|  Procedures | > more adjustable to individualize the fit of the      |
|             | > chair to a particular rider. There are two main      |
| **(cont.)** | > types of *independent manual mobility devices*,      |
|             | > namely conventional non-adjustable wheelchairs and   |
|             | > lighter weight, multi- adjustable wheelchairs.       |
|             |                                                        |
|             | -   Standard, conventional wheelchairs are used by     |
|             |     individuals who intend to traverse on smooth       |
|             |     ground and do not desire advanced mobility skills  |
|             |     such as ascending and descending curbs (Taylor,    |
|             |     et. al., 1997).                                    |
|             |                                                        |
|             | -   Multi-adjustable or lightweight wheelchairs are    |
|             |     designed to provide more maneuverability and       |
|             |     smoother operation for the active user.            |
|             |                                                        |
|             | > *Independent power mobility devices* are used by     |
|             | > individuals who do not have the functional ability   |
|             | > to self-propel a manual wheelchair, or by persons    |
|             | > for whom the physical strain of operating a manual   |
|             | > chair negatively impacts their mobility.             |
|             | > Restrictions in cardio-pulmonary capacity as well as |
|             | > physical limitations in the upper extremities can    |
|             | > indicate the need for power mobility. There are two  |
|             | > broad categories of *independent power mobility      |
|             | > devices*: power wheelchairs, and scooters.           |
|             |                                                        |
|             | -   Power wheelchairs are most often battery powered,  |
|             |     joystick operated, 4 wheeled, motor-driven chairs. |
|             |     Current designs use direct-drive motors attached   |
|             |     to two of the 4 wheels. These drive wheels may be  |
|             |     mounted at the rear of the chair (rear wheel       |
|             |     drive), under the seat (mid-wheel drive) or at the |
|             |     front of the chair (front wheel drive). The power  |
|             |     unit (batteries, motors and controller and wheels) |
|             |     is frequently housed together in a power base and  |
|             |     the seat unit is mounted to the top of the power   |
|             |     base. This modular power-base design adds          |
|             |     significant weight (as compared to a scooter), but |
|             |     is particularly advantageous to individuals who    |
|             |     frequently encounter uneven or rough terrain       |
|             |     (Cook, A. & Hussey, S., 1995). For users who are   |
|             |     unable to operate a joystick, alternate            |
|             |     controllers (Sip 'N Puff, breath controller, Head  |
|             |     controller) may be substituted for the joystick to |
|             |     control many of these power wheelchairs.           |
|             |                                                        |
|             | -   Scooters are available in either three or four     |
|             |     wheel designs. Most often a scooter is operated    |
|             |     through a tiller,                                  |
+-------------+--------------------------------------------------------+

Continued on next page

+-------------+--------------------------------------------------------+
| ##### 7.    | > which is used to control the direction of travel and |
|             | > a lever on the tiller, which controls speed. These   |
| ##### Alt   | > devices are most commonly utilized by individuals    |
| ernative Pr | > who are able to ambulate, but are limited in speed   |
| actices and | > and range of ambulation. The wheels are mounted to a |
|  Procedures | > platform to which the tiller is mounted, on the      |
|             | > front, and a seat is mounted on the rear. The        |
| ##          | > section of the platform between the tiller and the   |
| ### (cont.) | > seat serve as a footrest.                            |
|             |                                                        |
|             | Regardless of the type of wheeled mobility device a    |
|             | person uses, there are two major barriers that users   |
|             | commonly experience:                                   |
|             |                                                        |
|             | -   transporting the mobility device in a car          |
|             |                                                        |
|             | ```{=html}                                             |
|             | <!-- -->                                               |
|             | ```                                                    |
|             | -   ascending and descending stairs                    |
|             |                                                        |
|             | People who use wheeled mobility devices also want      |
|             | access to motor vehicles, such as cars or vans, either |
|             | as a passenger or as an operator. However, two         |
|             | obstacles pose impediments: accessing the vehicle and  |
|             | stowing the mobility device inside the motor vehicle.  |
|             |                                                        |
|             | Two door sedans are the most commonly used cars, by    |
|             | persons independently operating a manual wheelchair,   |
|             | because of their wide door opening. The user transfers |
|             | into a car independently or with the assistance of a   |
|             | transfer board or overhead grab bar. Once in the car,  |
|             | the user must find a way to safely stow the mobility   |
|             | device. Many manual wheelchair users are able to fold  |
|             | and pull the device inside the car while others        |
|             | require an assistant to place the device in the trunk, |
|             | back seat or on a special carrier on the back bumper   |
|             | of the car.                                            |
|             |                                                        |
|             | Scooter users, with sufficient ability to walk from    |
|             | the back of the car to the passenger compartment, may  |
|             | use a commercial lift to lift the scooter in and out   |
|             | of the back of the car. Once the scooter is loaded,    |
|             | the rider walks to the car door and gets into the car. |
|             |                                                        |
|             | If the user is unable to transfer into and out of a    |
|             | car, or uses a power wheelchair, then he/she will most |
|             | often use a modified van. (Van modifications may       |
|             | include raising the roof, dropping the floor, or       |
|             | both.) Two aids are commonly used to assist in         |
|             | accessing a van are ramps and lifts. The selection of  |
|             | either a ramp or a lift depends upon the person's need |
|             | to independently access the van and negotiate entry    |
|             | and exit from the van.                                 |
+-------------+--------------------------------------------------------+

Continued on next page

+-------------+--------------------------------------------------------+
| ##### 7.    | Ascending and descending stairs typically poses a      |
|             | problem for an individual using a wheeled mobility     |
| ##### Alt   | device. Some very highly, physically capable, manual   |
| ernative Pr | wheelchair riders are able to descend                  |
| actices and |                                                        |
|  Procedures | stairs by keeping their chair in a wheelie position    |
|             | and controlling the descent of the chair one step at a |
| ##          | time. Many of these very active users will go up       |
| ### (cont.) | stairs by getting out of their wheelchair, and "bump"  |
|             | up each stair with their arms, bringing their          |
|             | wheelchair up with them.                               |
|             |                                                        |
|             | Other wheelchair users need to rely on some type of    |
|             | mechanical assistance or significant physical          |
|             | assistance by one or more unimpaired persons.          |
|             |                                                        |
|             | -   Mechanical lifts have been developed to assist     |
|             |     people who use mobility devices in ascending and   |
|             |     descending stairs. For example, electric stair     |
|             |     chairs (stair glide) can                           |
|             |                                                        |
|             | be installed on a staircase. With this type of device, |
|             | the individual must transfer to the stair chair, which |
|             | will                                                   |
|             |                                                        |
|             | transport them between floors. When the stair chair    |
|             | reaches its destination, the person transfers again,   |
|             | either to a second device that stays on the other      |
|             | level of the house, or to their own device, which has  |
|             | been transported up or down the stairs by an           |
|             | assistant.                                             |
|             |                                                        |
|             | -   Elevators or electric lifts that fit over the      |
|             |     stairs can transport the person, as well as their  |
|             |     mobility device, from one floor to another.        |
|             |                                                        |
|             | -   To provide access to more than one particular      |
|             |     staircase, attendant operated stair climbing       |
|             |     devices have been developed. The device is         |
|             |     attached to the back of a manual wheelchair, and   |
|             |     the assistant uses it on the stairs in a manner    |
|             |     similar to a dolly or hand truck.                  |
|             |                                                        |
|             | -   To be manually assisted up (and in many cases down |
|             |     the stairs), a manual wheelchair rider can guide   |
|             |     one, preferably two assistants in "bumping" the    |
|             |     chair up the stairs. The chair and rider are       |
|             |     positioned in a wheelie position, one assistant is |
|             |     using the chair push handles, from behind, while a |
|             |     second assistant is positioned at the front of the |
|             |     chair holding on to the frame of the chair. The    |
|             |     rider, if possible, pulls back on the wheels,      |
|             |     while the assistants are lifting the chair up to   |
|             |     the next step. This sequence is repeated for each  |
|             |     step and reversed when coming down the steps.      |
|             |                                                        |
|             | Determination of which type of assisted mobility       |
|             | device a person needs is often made with consideration |
|             | of many factors including, physical ability, mobility  |
|             | requirements, environments of use, available service   |
|             | support. Increasingly evidence is emerging that the    |
|             | "use it or lose it" philosophy underlying many         |
|             | mobility recommendations is having long term           |
|             | detrimental effects of the user of assisted mobility   |
+-------------+--------------------------------------------------------+

Continued on next page

+-------------+--------------------------------------------------------+
| ##### 7.    | devices. Studies, particularly involving persons with  |
|             | a spinal cord injury, indicate the prevalence of       |
| ##### Alt   | shoulder pain in wheelchair riders to range from 36%   |
| ernative Pr | to 73%, with an apparent increase in prevalence the    |
| actices and | longer the person has lived with the disability. (Sie, |
|  Procedures | et al, 1992; Pentland, 1991; Subbarao, 1994). These    |
|             | reports of secondary complication to long term, daily  |
| ##          | use of manual mobility devices are beginning to impact |
| ### (cont.) | the recommendations for when a person is best suited   |
|             | for a manual versus a powered mobility device.         |
|             |                                                        |
|             | # BIBLIOGRAPHY                                         |
|             |                                                        |
|             | Cook, Albert & Hussey, Susan. (1995). [Assistive       |
|             | Technology: Principles and Practice]{.underline}. St.  |
|             | Louis, Missouri: Mosby-Year Book, Inc.                 |
|             |                                                        |
|             | LaPlante, Mitchell P., Hendershot, Gerry E., Moss,     |
|             | Abigail J. (1992). Assistive Technology Devices and    |
|             | Home Accessibility Features: Prevalence, Payment,      |
|             | Need, and Trends. [Advance Data, (217)]{.underline}:   |
|             | 1-12.                                                  |
|             |                                                        |
|             | > Sprigle, Stephen & Lane, Joseph P. (1995). Assistive |
|             | > Technology for Persons with Physical Disabilities In |
|             | > Mann, William C. & Lane, Joseph P. (Eds.).           |
|             | > [Assistive Technology for Persons with               |
|             | > Disabilities]{.underline} (2^nd^ ed.). Bethesda,     |
|             | > Maryland: American Occupational Therapy Association, |
|             | > Inc. 74-81.                                          |
|             | >                                                      |
|             | > Taylor, Susan Johnson & Kreutz, David. (1997).       |
|             | > Powered and Manual Wheelchair Mobility. In Angelo,   |
|             | > Jennifer (Ed.). [Assistive Technology for            |
|             | > Rehabilitation Therapists]{.underline}.              |
|             | > Philadelphia, PA: F.A. Davis Company. 117-154.       |
|             |                                                        |
|             | Sie IH, Waters RL, Adkins RH, Gellman H: Upper         |
|             | extremity pain in the postrehabilitation spinal cord   |
|             | injured person. [Arch Phys Med                         |
|             | Rehabilitation]{.underline} 1992;73:44-48.             |
|             |                                                        |
|             | Pentland WE, Twomet LT: The weight-bearing upper       |
|             | extremity in women with long term paraplegia.          |
|             | [PARAPLEGIA]{.underline} 1991; 29:521-530.             |
|             |                                                        |
|             | > Subbarao JV, Klopfstein J, Turpin R: Prevalence and  |
|             | > impact of wrist and shoulder pain in patients with   |
|             | > spinal cord injury. [J Spinal Cord                   |
|             | > Medicine]{.underline} 1994; 18: 9-13.                |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 8.    | > The INDEPENDENCE™ iBOT™ 3000 Mobility System has     |
|             | > never been offered for sale, and therefore, has no   |
| **Marketing | > marketing history.                                   |
| History**   |                                                        |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| #####  9.   | > The adverse events listed can occur while using the  |
|             | > INDEPENDENCE™ iBOT™ 3000 Mobility System as well as  |
| **Adverse   | > any power wheelchair:                                |
| Events**    |                                                        |
|             | -   Pinching/crushing finger/hands when lowering seat  |
|             |                                                        |
|             | -   User falls out of the product                      |
|             |                                                        |
|             | -   Product falls over either forward or backward      |
|             |                                                        |
|             | -   Product falls over laterally (sideways)            |
|             |                                                        |
|             | -   Product becomes inoperable                         |
|             |                                                        |
|             | -   Product goes off the edge of obstacles or stairs   |
|             |                                                        |
|             | -   User collides with obstacles                       |
|             |                                                        |
|             | -   User or product injures other people               |
|             |                                                        |
|             | -   User suffer injury while attempting to climb       |
|             |     > stairs                                           |
|             |                                                        |
|             | -   Assistant is injured                               |
|             |                                                        |
|             | -   User injured during transfers                      |
|             |                                                        |
|             | -   Electrical Shock                                   |
|             |                                                        |
|             | > The potential risks listed can result in, but are    |
|             | > not limited to:                                      |
|             |                                                        |
|             | -   Crushing injury                                    |
|             |                                                        |
|             | -   Contusions                                         |
|             |                                                        |
|             | -   Abrasions                                          |
|             |                                                        |
|             | -   Lacerations                                        |
|             |                                                        |
|             | -   Concussion                                         |
|             |                                                        |
|             | -   Fractures                                          |
|             |                                                        |
|             | -   Head injuries                                      |
|             |                                                        |
|             | -   Internal injuries                                  |
|             |                                                        |
|             | -   Burns                                              |
|             |                                                        |
|             | -   Death                                              |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 10.   | > A summary of the (a) non-clinical laboratory studies |
|             | > and the (b) clinical investigations submitted in the |
| **Summary   | > PMA application.                                     |
| of          |                                                        |
| Studies**   |                                                        |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 10 a. | > The INDEPENDENCE™ iBOT™ 3000 Mobility System has     |
|             | > been tested to a wide range of non-clinical tests    |
| **          | > quantifying the software, mechanical, electrical,    |
| Nonclinical | > performance, environmental, and anomalous device     |
| Studies**   | > characteristics.                                     |
|             |                                                        |
|             | The software information includes the software         |
|             | development process, risk management, and              |
|             | comprehensive verification and validation. The         |
|             | documentation describing these activities is           |
|             | consistent with the recommendations of the FDA         |
|             | *Guidance for the Content of Premarket Submissions for |
|             | Software Contained in Medical Devices* (5/29/98).      |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 a. | > To test the mechanical, electrical, environmental,   |
|             | > performance and anomalous properties of the          |
| **          | > INDEPENDENCE™ iBOT™ 3000 Mobility System many of the |
| Nonclinical | > CDRH Recognized Consensus Standards were used as the |
| Studies     | > basis for testing. A list of the consensus standards |
| (cont.)**   | > used is as follows:                                  |
|             |                                                        |
|             | -   ANSI RESNA WC/08-1991 Wheelchairs -- Static,       |
|             |     > Impact and Fatigue Strength Tests                |
|             |                                                        |
|             | -   ANSI RESNA WC/21-Vol.2-1998 Requirements and test  |
|             |     > methods for electromagnetic compatibility of     |
|             |     > powered wheelchairs ad motorized scooters        |
|             |                                                        |
|             | -   ISO 7176-3:1988 Wheelchairs -- Part 3:             |
|             |     > Determination of Efficiency of Brakes            |
|             |                                                        |
|             | -   ISO 7176-4:1997 Wheelchairs -- Part 4: Energy      |
|             |     > Consumption of Electric Wheelchairs and Scooters |
|             |     > for Determination of Theoretical Distance Range  |
|             |                                                        |
|             | -   ISO 7176-5:1986 Wheelchairs -- Part 5:             |
|             |     > Determination of Overall Dimensions, Mass and    |
|             |     > Turning Space                                    |
|             |                                                        |
|             | -   ISO 7176-9:1988 Wheelchairs -- Part 9: Climatic    |
|             |     > tests for electric wheelchairs                   |
|             |                                                        |
|             | -   ISO 7176-14:1997 Wheelchairs -- Part 14: Power and |
|             |     > Control Systems for Electric Wheelchairs --      |
|             |     > Requirements and Test Methods.                   |
|             |                                                        |
|             | -   ISO 7176-15:1996 Wheelchairs -- Part 15:           |
|             |     > Requirements for Information Disclosure,         |
|             |     > Documentation and Labeling                       |
|             |                                                        |
|             | ```{=html}                                             |
|             | <!-- -->                                               |
|             | ```                                                    |
|             | -   ISO 7176-16:1997 Wheelchairs -- Part 16:           |
|             |     > Resistance to Ignition of Upholstered Parts --   |
|             |     > Requirements and Test Method                     |
|             |                                                        |
|             | -   ISO 7176-1:1999 Wheelchairs -- Part 1:             |
|             |     > Determination of Static Stability                |
|             |                                                        |
|             | -   ISO 7176-10:1988 Wheelchairs -- Part 10:           |
|             |     > Determination of Obstacle-Climbing Ability of    |
|             |     > Electric Wheelchairs                             |
|             |                                                        |
|             | > The INDEPENDENCE™ iBOT™ 3000 Mobility System was     |
|             | > tested to many other international standards such    |
|             | > as:                                                  |
|             |                                                        |
|             | -   ANSI RESNA WC/15-Vol.1-1998 Requirements for       |
|             |     > Information Disclosure, Documentation and        |
|             |     > Labeling                                         |
|             |                                                        |
|             | -   ANSI RESNA WC/19-Vol.1-1998 Requirements and Test  |
|             |     > Methods for Wheelchairs (Including Scoters),     |
|             |     > Section 19: Wheelchairs Used as Seats in Motor   |
|             |     > Vehicles                                         |
|             |                                                        |
|             | -   ASTM D 4169-01 Standard Practice for Performance   |
|             |     > Testing of Shipping Containers and Systems       |
|             |                                                        |
|             | -   ASTM D 6179-97 Standard Test Methods for Rough     |
|             |     > Handling of Unitized Loads and Large Shipping    |
|             |     > Cases and Crates                                 |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 a. | -   ASTM D 4003-98 Standard Test Methods for           |
|             |     > Programmable Horizontal Impact Test for Shipping |
| **          |     > Containers and Systems                           |
| Nonclinical |                                                        |
| Studies     | -   ASTM D 642-00 Standard Test Method for Determining |
| (cont.)**   |     > Compressive Resistance of Shipping Containers,   |
|             |     > Components and Unit Loads                        |
|             |                                                        |
|             | -   ASTM D 999-01 Standard Test Methods for Vibration  |
|             |     > Testing of Shipping Containers                   |
|             |                                                        |
|             | -   ASTM D 4728-01 Standard Test Method for Random     |
|             |     > Vibration Testing of Shipping Containers         |
|             |                                                        |
|             | -   BS EN 12184:1999 Electrically Powered Wheelchairs, |
|             |     > Scooters and Their Chargers -- Requirements and  |
|             |     > Test Methods                                     |
|             |                                                        |
|             | -   CISPR-11:1990 Limits and methods of measurement of |
|             |     > electromagnetic disturbance characteristics of   |
|             |     > industrial, scientific and medical (ISM)         |
|             |     > radio-frequency equipment                        |
|             |                                                        |
|             | -   IEC 61000-4-2:1995 Electromagnetic Compatibility   |
|             |     > (EMC) Part 4: Testing & Measurement Techniques   |
|             |     > -- Section 2: Electrostatic discharge immunity   |
|             |     > test                                             |
|             |                                                        |
|             | -   IEC 61000-4-3:1995 Electromagnetic Compatibility   |
|             |     > (EMC) Part 4: Testing & Measurement Techniques   |
|             |     > -- Section 3: Radiated, Radio-Frequency,         |
|             |     > Electromagnetic Field Immunity Test              |
|             |                                                        |
|             | > > IEC 61000-4-4:1995 Electromagnetic Compatibility   |
|             | > > (EMC) Part 4: Testing & Measurement Techniques --  |
|             | > > Section 4: Radiated, Radio-Frequency,              |
|             | > > Electromagnetic Field Immunity Test                |
|             |                                                        |
|             | -   IEC 61000-4-5:1995 Electromagnetic Compatibility   |
|             |     > (EMC) Part 4: Testing & Measurement Techniques   |
|             |     > -- Section 5: Radiated, Radio-Frequency,         |
|             |     > Electromagnetic Field Immunity Test              |
|             |                                                        |
|             | -   IEC 60529:1989-11: Classification of Degrees of    |
|             |     > Protection Provided by Enclosures                |
|             |                                                        |
|             | -   IEC 60335-1 Third Edition 1991-04 Safety of        |
|             |     > Household and Similar Electrical Appliances,     |
|             |     > Part 1: General Requirements                     |
|             |                                                        |
|             | -   IEC 60601-1 second edition 1998, Medical           |
|             |     > electrical equipment part 1: General             |
|             |     > requirements for safety                          |
|             |                                                        |
|             | -   IEC 68-2-14 Fifth Edition 1984: Basic              |
|             |     > Environmental Testing Procedures, Part 2:        |
|             |     > Test-Test N: Change of Temperature               |
|             |                                                        |
|             | -   ISO 7176-2:1999 Wheelchairs -- Part 2:             |
|             |     > Determination of Dynamic Stability of Electric   |
|             |     > Wheelchairs                                      |
|             |                                                        |
|             | -   ISO7176-6:2001 Wheelchairs -- Part 6:              |
|             |     > Determination of Maximum Speed, Acceleration and |
|             |     > Retardation of Electric Wheelchairs              |
|             |                                                        |
|             | -   ISO 7176-7:1998 Wheelchairs -- Part 7: Measurement |
|             |     > of Seating and Wheel Dimensions                  |
|             |                                                        |
|             | -   ISO 7176-8:1998 Wheelchairs -- Part 8:             |
|             |     > Requirements and Test Methods for Static, Impact |
|             |     > and Fatigue Tests                                |
|             |                                                        |
|             | -   ISO 7176-9:1997 Wheelchairs -- Part 9: Climatic    |
|             |     > Tests for Electric Wheelchairs                   |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 a. | -   ISO 7176-9:2001 Wheelchairs -- Part 9: Climatic    |
|             |     > Tests for electric wheelchairs                   |
| **          |                                                        |
| Nonclinical | -   ISO 7176-20:1996 Wheelchairs -- Part 20: Stand-up  |
| Studies     |     > type wheelchairs                                 |
| (cont.)**   |                                                        |
|             | -   ISO 7176-21:1999 Wheelchairs -- Part 21:           |
|             |     > Requirements and Test Methods for                |
|             |     > Electromagnetic Compatibility of Electric        |
|             |     > Powered Wheelchairs and Scooters                 |
|             |                                                        |
|             | -   ISO 8191-1:1987 Furniture -- Assessment of the     |
|             |     > ignitability of upholstered furniture -- Part 1: |
|             |     > Ignition source -- smoldering cigarette          |
|             |                                                        |
|             | -   ISO 8191-2:1988 Furniture -- Assessment of the     |
|             |     > ignitability of upholstered furniture -- Part 2: |
|             |     > Ignition source -- match- flame equivalent       |
|             |                                                        |
|             | -   ISO 10993-1:1994 Biological evaluation of medical  |
|             |     > devices Part 1. Guidance on selection of tests   |
|             |                                                        |
|             | -   ISO 10993-5:1999 Biological evaluation of medical  |
|             |     > devices Part 5. Tests for in vitro cytotoxicity  |
|             |                                                        |
|             | -   ISO 10993-10:1995 Biological evaluation of medical |
|             |     > devices Part 10. Tests for irritation and        |
|             |     > sensitization                                    |
|             |                                                        |
|             | -   MIL-STD 810E Method 510.3 July 14 1989 Department  |
|             |     > of Defense Tests Methods Standard for            |
|             |     > Environmental Engineering Considerations and     |
|             |     > Laboratory Tests -- Sand and Dust                |
|             |                                                        |
|             | -   MIL-STD 810E Method 505.3 Solar Radiation          |
|             |     > (Sunshine)                                       |
|             |                                                        |
|             | -   UL 1012, Power Units Other Than Class 2            |
|             |                                                        |
|             | > All these standards were used to create the test     |
|             | > plans and test cases that the mobility system was    |
|             | > tested to. Data is presented in the following test   |
|             | > reports: 1) Static Stability 2) Dynamic Stability 3) |
|             | > Effectiveness of Brakes 4) Electrical Energy         |
|             | > Consumption and Distance Range 5) Dimensions, Mass   |
|             | > and Turning Space 6) Speed, Acceleration, and        |
|             | > Retardation 7) Measurement of Seating and Wheel      |
|             | > Dimensions 8) Static Impact & Fatigue 9) Climate 10) |
|             | > Obstacle Climbing Ability 11) Power and Control      |
|             | > Systems 12) Nomenclature and Labeling 13) Resistance |
|             | > to Ignition of Upholstered Parts                     |
|             | >                                                      |
|             | > 14\) Electromagnetic Compatibility 15) Stair         |
|             | > Climbing 16) Fault Insertion 17) System Monitoring   |
|             | > 18) Programmable Drive Parameters 19) Stability With |
|             | > Impact 20) Crack Traversal 21) User Control Panel    |
|             | > 22) Transporter Power 23) Computer Interface 24)     |
|             | > Exposure to Altitude 25) Transitions Between         |
|             | > Functions 26) Enclosures Protection 27) Electrical   |
|             | > Standards 28) Safety 29) User Comfort and            |
|             | > Convenience 30) Packaging 31) Lifetime 32) Operation |
|             | > On Surfaces 33) Environmental 34) Joystick           |
|             | > Mechanical 35) Drop Test                             |
|             | >                                                      |
|             | > 36\) Exposure to Sunlight                            |
|             | >                                                      |
|             | > All results met the pass/fail criteria that have     |
|             | > been established.                                    |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 b. | There is a Pivotal Trial for the INDEPENDENCE™ iBOT™   |
|             | 3000 Mobility System. It is the only study in which    |
| #####       | individuals with a mobility disability received the    |
| Clinical In | training program that will be used when the device is  |
| vestigation | marketed and utilized in uncontrolled environments for |
|             | an extended period of time. This is the only study     |
|             | capable of generating data regarding the safe and      |
|             | effective use of the device for its intended           |
|             | population.                                            |
|             |                                                        |
|             | In addition to the Pivotal Trial there are three (3)   |
|             | additional clinical evaluations utilizing the          |
|             | investigational device. These three clinical           |
|             | evaluations pre-dated the Pivotal Trial and as such    |
|             | utilized previous versions of both the INDEPENDENCE™   |
|             | iBOT™ 3000 Mobility System and the training program    |
|             | for the device. While these additional clinical        |
|             | evaluations were not designed to evaluate the safe and |
|             | effective use of the investigational device, the       |
|             | information generated by these studies was helpful in  |
|             | designing the investigational device and the Pivotal   |
|             | Clinical Trial. Because these additional clinical      |
|             | evaluations were not designed to evaluate the safe and |
|             | effective use of the investigational device they are   |
|             | not summarized here.                                   |
|             |                                                        |
|             | # PIVOTAL CLINICAL TRIAL SUMMARY                       |
|             |                                                        |
|             | # PRINCIPLE INVESTIGATOR                               |
|             |                                                        |
|             | Heikki Uustal, MD, Department of Rehabilitation        |
|             | Medicine, JFK - Johnson Rehabilitation Institute,      |
|             | Edison, NJ                                             |
|             |                                                        |
|             | # SUBINVESTIGATORS                                     |
|             |                                                        |
|             | Lei Lin, MD, Jean Minkel, PT, Hunter Burgess, PT,      |
|             | Maria Bemont, PT, Sandy Salerno, OT, Stacey Eberhardt, |
|             | OT, Ann Greiner, PT, Lynne Corriveau, PT, Kevin        |
|             | Corriveau, PT, Jennifer Stafford, OT                   |
|             |                                                        |
|             | # INSTITUTIONAL REVIEW BOARD                           |
|             |                                                        |
|             | New England Institutional Review Board, Wellesley, MA  |
|             |                                                        |
|             | # OBJECTIVE                                            |
|             |                                                        |
|             | This study had two main objectives:                    |
|             |                                                        |
|             | 1.  To demonstrate that people with a variety of       |
|             |     mobility skills (different capabilities), using    |
|             |     different configurations of the INDEPENDENCE™      |
|             |     iBOT™ 3000 Mobility System, will be able to safely |
|             |     and effectively use the product in real world      |
|             |     environments.                                      |
|             |                                                        |
|             | ```{=html}                                             |
|             | <!-- -->                                               |
|             | ```                                                    |
|             | 1.  To demonstrate that subjects will have             |
|             |     improvements in both objective and subjective      |
|             |     measures of functional activities in a real world  |
|             |     environment when using the INDEPENDENCE™ iBOT™     |
|             |     3000 Mobility System compared to their current     |
|             |     device.                                            |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 b. | **EXPERIMENTAL DESIGN**                                |
|             |                                                        |
| #####       | The clinical trial was a single center, prospective,   |
| Clinical In | balanced, open label evaluation that utilized          |
| vestigation | participants as their own control. A total of 20       |
|             | Subjects were required to complete the study. The      |
| **(cont.)** | initial two (2) Subjects (skilled manual wheelchair    |
|             | users) completed the Pilot Trial, eighteen (18)        |
|             | Subjects completed the Real World Trial. By design     |
|             | these 18 Subjects consisted of 6 skilled manual        |
|             | wheelchair users, 6 slow manual wheelchair users, and  |
|             | 6 power wheelchair users.                              |
|             |                                                        |
|             | The safety of the investigational device was           |
|             | determined by comparing the rate of adverse events     |
|             | occurring in the investigational device and in the     |
|             | subjects' own devices.                                 |
|             |                                                        |
|             | The primary efficacy variable in this study was the    |
|             | score a subject obtained on a Community Driving Test   |
|             | consisting of 15 tasks that one would encounter in     |
|             | everyday life. The scoring system was a 7 point scale. |
|             | The lowest score (0) was assigned when a subject could |
|             | not do a task. The next 3 scores (1, 2, 3) were        |
|             | assigned when a subject could do the task with the     |
|             | assistance of someone else (scores within this group   |
|             | were differentiated by the level of exertion required  |
|             | by the assistant).                                     |
|             |                                                        |
|             | The highest three scores (4, 5, 6) were assigned when  |
|             | the subject could do the task independently (scores    |
|             | within this group were differentiated by the level of  |
|             | exertion required by the subject). Changes from one    |
|             | group to another show a change in the subject's        |
|             | independence level. Changes within a group show no     |
|             | change in independence, but a change in exertion       |
|             | required to complete the task.                         |
|             |                                                        |
|             | The secondary efficacy variable was also the ability   |
|             | to do specific tasks and they were scored in the same  |
|             | manner as the primary efficacy variable. However,      |
|             | these tasks were ones that each subject chose as being |
|             | important to them in their life.                       |
|             |                                                        |
|             | The Wilcoxon Signed Rank test was utilized to test for |
|             | a difference in efficacy variable scores between the   |
|             | investigational device and the subjects' own device.   |
|             |                                                        |
|             | # STUDY PERIOD                                         |
|             |                                                        |
|             | The study was conducted from February 2002 to May      |
|             | 2002. Each Pilot Trial subject participated in the     |
|             | study for two weeks; one week in their own device and  |
|             | one week in the investigational device. Each Real      |
|             | World Trial subject participated in the study for four |
|             | weeks; two weeks in their own device and two weeks in  |
|             | the investigational device.                            |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 b. | # STUDY POPULATION                                     |
|             |                                                        |
| #####       | # The study population consisted of indivi             |
| Clinical In | duals currently using a manual wheelchair, a power whe |
| vestigation | elchair or a scooter as their primary mobility device. |
|             |                                                        |
| **(cont.)** | #                                                      |
|             |                                                        |
|             | # SUBJECT SELECTION                                    |
|             |                                                        |
|             | The key inclusion criteria was subject willingness to  |
|             | use a wheelchair accessible van or accessible public   |
|             | transportation during the study. The key exclusion     |
|             | criteria were a subject weight of more than 250 lbs.,  |
|             | the subject living outside of the investigational      |
|             | device service area, numerous criteria related to the  |
|             | subject's physical capabilities to operate the         |
|             | investigational device, and numerous criteria related  |
|             | to the subject's medical condition. Subjects who met   |
|             | the inclusion/exclusion criteria signed an Informed    |
|             | Consent to participate. A trained clinician performed  |
|             | an assessment to determine if the subject was          |
|             | appropriate for the study. Subjects were trained in    |
|             | the use of the investigational device and required to  |
|             | demonstrate proficiency with the device.               |
|             |                                                        |
|             | # HOW DATA WAS COLLECTED                               |
|             |                                                        |
|             | Safety data was collected on a daily basis through     |
|             | telephone contact with the subject. Efficacy data was  |
|             | collected when the subject completed the Community     |
|             | Driving Test after having utilized the investigational |
|             | device in the Real World for two weeks.                |
|             |                                                        |
|             | # SUBJECT DISCONTINUATION                              |
|             |                                                        |
|             | A total of twenty-nine (29) subjects signed the        |
|             | informed consent. Eight (8) subjects never received    |
|             | training in the investigation. Two (2) of the eight    |
|             | were not recommended for the device by the clinician.  |
|             | Two (2) of the eight voluntarily withdrew from the     |
|             | study prior to training; one withdrew after suffering  |
|             | injuries in an automobile accident and the other       |
|             | withdrew because of issues related to transferring in  |
|             | and out of his van. The Sponsor ended the              |
|             | participation of four (4) of the eight subjects, two   |
|             | (2) because the desired sample size of power chair     |
|             | subjects had been reached, one because participation   |
|             | in the study would have required modifications to the  |
|             | subjects stairs outside his home, and one (1) because  |
|             | the subject had a potential conflict of interest.      |
|             |                                                        |
|             | Twenty-one (21) subjects received the Day 1 training   |
|             | on the use of the INDEPENDENCE™ iBOT™ 3000 Mobility    |
|             | System. Twenty (20) subjects completed the clinical    |
|             | trial. One (1) subject voluntarily ended their         |
|             | participation in the study after one day in the        |
|             | investigational device because it was difficult to     |
|             | operate the device in the small hallways and rooms of  |
|             | the subject's home.                                    |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 b. | # SAFETY DATA/ADVERSE EVENTS                           |
|             |                                                        |
| #####       | -   There were no serious adverse events \[any event   |
| Clinical In |     caused by or associated with the product that      |
| vestigation |     required medical treatment outside of the          |
|             |     Evaluation Facility or the subject's home\].       |
| **(cont.)** |                                                        |
|             | -   There was one adverse event \[any event caused by  |
|             |     or associated with the product that required       |
|             |     medical treatment by (a) the clinician at the      |
|             |     Evaluation Facility or (b) by the subject or       |
|             |     others at the subjects home\]. This event occurred |
|             |     during an assessment of the subject in the         |
|             |     investigational device. He pinched his forearm     |
|             |     between the UCP and the Armrest. A forearm pad was |
|             |     utilized to prevent further problems; no other     |
|             |     medical treatment was provided.                    |
|             |                                                        |
|             | -   There were four (4) instances of subjects seeking  |
|             |     medical attention for events that were not caused  |
|             |     or associated with the use of the device. In all   |
|             |     cases the subject was utilizing their own device.  |
|             |                                                        |
|             | -   There were five (5) instances which did not        |
|             |     require medical attention, but which could have    |
|             |     required medical attention should the event recur. |
|             |     All of the events were related to the device and   |
|             |     subject falling, three (3) of these events         |
|             |     occurred in the investigational device, two (2)    |
|             |     occurred in their own device. All events are       |
|             |     attributable to subject judgment errors; in no     |
|             |     event did a device fail or otherwise malfunction.  |
|             |                                                        |
|             | **EFFECTIVENESS DATA**                                 |
|             |                                                        |
|             | -   In the Community Driving Test all 20 subjects      |
|             |     scored higher in the investigational device than   |
|             |     in their own device. The result is statistically   |
|             |     significant (p\<.001).                             |
|             |                                                        |
|             | -   In the stair climbing components of the Community  |
|             |     Driving Test all 20 subjects scored higher in the  |
|             |     investigational device than in their own device.   |
|             |     The result is statistically significant (p\<.001). |
|             |                                                        |
|             | -   In every task (11) in the Community Driving Test   |
|             |     in which the Stair Climbing Function, the 4-Wheel  |
|             |     Function or the Balance Function in the            |
|             |     investigational device was utilized there was a    |
|             |     statistically significant improvement in test      |
|             |     scores and there was a statistically significant   |
|             |     (range from p\<.001 to p=.008) improvement in the  |
|             |     subject's level of independence.                   |
|             |                                                        |
|             | -   In the Subject Specific Function Scores subjects   |
|             |     scored significantly higher in the investigational |
|             |     device and there was a statistically significant   |
|             |     (p\<.001) improvement in the subject's level of    |
|             |     independence.                                      |
|             |                                                        |
|             | # SUBJECT COMPLAINTS                                   |
|             |                                                        |
|             | Telephone contact was made daily with subjects.        |
|             | Subjects were asked if they had any accessibility      |
|             | problems during the day, and if they had any           |
|             | mechanical or operational difficulties with the        |
|             | device.                                                |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 b. | A total of eighty-six (86) accessibility problems were |
|             | noted in their own device and seventy-nine (79) in the |
| #####       | investigational device. Accessibility issues in        |
| Clinical In | subjects' own devices are primarily related to         |
| vestigation | accessing a location (74 of 86). The data show the     |
|             | investigational device can help subjects overcome      |
| **(cont.)** | these currently non-accessible environments.           |
|             |                                                        |
|             | Accessibility issues in the investigational device are |
|             | primarily related to maneuvering the device (22 of 79) |
|             | and the high seat height (difficulty getting under     |
|             | tables, etc., 34 of 79). These difficulties may be     |
|             | minimized with increased subject experience with the   |
|             | device and future product modifications.               |
|             |                                                        |
|             | > A total of twenty-five (25) mechanical/operational   |
|             | > problems were noted in their own device and          |
|             | > fifty-nine (59) in the investigational device.       |
|             | > Disparities between the two groups appear to exist   |
|             | > for Battery difficulties (primarily low battery at   |
|             | > end of day, 3 in own device, 18 in investigational   |
|             | > device), User Control Paneldifficulties (0 versus 5) |
|             | > and User Technique difficulties (2 versus 11).       |
|             | > However, when in their own device Manual wheelchair  |
|             | > users (14 of 20 in this study) do not have batteries |
|             | > or a User Control Panel. Additionally, 6 of the 18   |
|             | > battery difficulties (low battery at end of day)     |
|             | > occurred on a Training Day where there was extensive |
|             | > use of the device. Recognizing this the only true    |
|             | > disparity between the two groups is in User          |
|             | > Technique difficulties. A review of the User         |
|             | > Technique difficulties indicates these are           |
|             | > difficulties that would be less likely to occur as   |
|             | > one gains experience with the device.                |
|             |                                                        |
|             | # DEVICE FAILURES AND REPLACEMENTS                     |
|             |                                                        |
|             | There were three (3) investigational device            |
|             | replacements in this study. Each of these could have   |
|             | been handled as a device component replacement,        |
|             | however, to minimize inconvenience to the subject the  |
|             | device was replaced.                                   |
|             |                                                        |
|             | In addition to these three occurrences that could have |
|             | been device component replacements, there were ten     |
|             | (10) other investigational device component            |
|             | replacements. There were a total of nine (9)           |
|             | occurrences where the subject reported device          |
|             | component replacements for their own chair.            |
|             |                                                        |
|             | # CONTRAINDICATIONS AND PRECAUTIONS                    |
|             |                                                        |
|             | > Contraindications are the Inclusion/Exclusion        |
|             | > criteria from the clinical study and presented in    |
|             | > product labeling. Precautions are presented          |
|             | > throughout the product labeling as Warnings and      |
|             | > Cautions.                                            |
+-------------+--------------------------------------------------------+

*Continued on next page*

+-------------+--------------------------------------------------------+
| ##### 10 b. | # CONCLUSIONS                                          |
|             |                                                        |
| #####       | > The safety of the INDEPENDENCE™ iBOT™ 3000 Mobility  |
| Clinical In | > System has been demonstrated by showing the safety   |
| vestigation | > profile for the device is comparable to the safety   |
|             | > profile for the subject's own device.                |
| **(cont.)** |                                                        |
|             | The effectiveness of the INDEPENDENCE™ iBOT™ 3000      |
|             | Mobility System has been demonstrated by showing a     |
|             | statistically significant improvement in the primary   |
|             | and secondary efficacy variables.                      |
|             |                                                        |
|             | The effectiveness data demonstrates the clinical       |
|             | utility of the INDEPENDENCE™ iBOT™ 3000 Mobility       |
|             | System. The Balance Function, 4-Wheel Function and     |
|             | Stair Function features of this device increase the    |
|             | independence of individuals with a disability.         |
|             |                                                        |
|             | > As shown by the comparable safety profile, there is  |
|             | > little, if any, risk associated with using the       |
|             | > INDEPENDENCE™ iBOT™ 3000 Mobility System when        |
|             | > compared to current mobility devices. As shown by    |
|             | > the efficacy data, there is significant benefit      |
|             | > associated with using the INDEPENDENCE™ iBOT™ 3000   |
|             | > Mobility System when compared to current mobility    |
|             | > devices.                                             |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| #####  11.  | Based on the Nonclinical and clinical studies          |
|             | presented, Compared to currently used manual and       |
| **          | powered mobility devices the INDEPENDENCE™ iBOT™ 3000  |
| Conclusions | Mobility System, when used for its intended use and    |
| Drawn from  | conditions of use, and accompanied by adequate         |
| the         | directions for use and warnings against unsafe use,    |
| Studies**   | will provide clinically significant results with       |
|             | little, if any, additional risk.                       |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 12.   | > TBD                                                  |
|             |                                                        |
| **Panel     |                                                        |
| Recomm      |                                                        |
| end-ation** |                                                        |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| ##### 13.   | > TBD                                                  |
|             |                                                        |
| ##### CD    |                                                        |
| RH Decision |                                                        |
+-------------+--------------------------------------------------------+

+-------------+--------------------------------------------------------+
| **14.**     |                                                        |
|             |                                                        |
| **Approval  |                                                        |
| Spec        |                                                        |
| ification** |                                                        |
+-------------+--------------------------------------------------------+