This guidance was written prior to the February 27, 1997 implementation of FDAs Good
Guidance Practices, GGPs. It does not create or confer rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute, regulations, or both. This guidance will be
updated in the next revision to include the standard elements of GGPs.
GUIDANCE DOCUMENT FOR THE PREPARATION OF
PREMARKET NOTIFICATION [510(K)] APPLICATIONS FOR
MECHANICAL AND POWERED WHEELCHAIRS, AND
MOTORIZED THREE-WHEELED VEHICLES
July 26, 1995
(reformatted 12/18/97)
This guidance document may contain references to addresses and telephone numbers that
are now obsolete.  The following contact information is to be used instead:
(cid:1) While this guidance document represents a final document, comments and suggestions
may be submitted at any time for Agency consideration to the Restorative Devices
Branch, 9200 Corporate Blvd., HFZ-410, Rockville, MD  20850.
(cid:1) For questions regarding the use or interpretation of this guidance, contact the
Restorative Devices Branch at 301-594-1296.
(cid:1) To contact the Division of Small Manufacturers Assistance (DSMA), call 800-638-2041
or 301-443-6597; fax 301-443-8818; email dsmo@cdrh.fda.gov; or write to DSMA
(HFZ-200), Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 
20850-4307.  FACTS-ON-DEMAND (800-899-0381 or 301-827-0111) and the World
Wide Web (CDRH home page: http://www.fda.gov/cdrh/index.html) also provide easy
access to the latest information and operating policies and procedures.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, MD  20850
page 1 PREFACE
The purpose of this document is to provide guidance to the sponsors of premarket notifications
[510(k)'s] for restorative devices.  This document is intended to assist the sponsors in organizing
and  providing  the  essential  information  that  should  be  submitted  to  the  Food  and  Drug
Administration (FDA) for review.
This guidance is based on the Restorative Devices Branch's (REDB's) identification of specific
criteria necessary to conduct an adequate evaluation of a 510(k) for the purpose of determining
substantial equivalence for physical medicine/restorative devices.  The objective of this document is
to  delineate  to  the  device  manufacturer  important  administrative,  descriptive,  and  scientific
information  that  should  be  included  in  a  510(k)  for  a  restorative  device.    Individual  510(k)
submissions may require additional information pertinent to each specific device.  The suggestions
and recommendations included in the guidance reflect the minimal requirements that would allow
an evaluation of the device as determined by REDB.  While the use of this document in the
preparation of a 510(k) premarket notification will not ensure FDA clearance of a device, following
the guidance will ensure that sufficient basic information is available to initiate a substantive
review.
Note that the guidance document is a living document.  It will be periodically revised as scientific
knowledge and regulations change.
Guidance document preparation was accomplished by the joint efforts of the REDB staff.
page 2 INTRODUCTION
Any 510(k) notification submitted under premarket notification procedures described in 21 Code of
Federal Regulations (CFR) Part 807, Subpart E, for FDA's determination that a new device is
substantially  equivalent  to  a  predicate  (existing)  device  in  21  CFR  890.3850  (Mechanical
Wheelchair),  21  CFR  890.3860  (Powered  Wheelchair),  21  CFR  890.3880  (Special  Grade
Wheelchair),  21  CFR  890.3890  (Stair-climbing  Wheelchair),  21  CFR  890.3900  (Standup
Wheelchair), and 21 CFR 890.380 (Motorized Three-wheeled Vehicle) should follow the format
below and must contain all specified information that is applicable to the device.
ADMINISTRATIVE INFORMATION
1. Provide the name and address of the manufacturer and sponsor of the 510(k) submission.
2. Provide the FDA registration number (if available) of the manufacturer of the new device.
3. Identify the official contact person for all correspondence.
DEVICE IDENTIFICATION
1. As stated in 21 CFR 807.90(d), a 510(k) shall be submitted separately for each product the
manufacturer intends to market.  Therefore, a submission can describe no more than one
new device.
A submission can describe more than one component of, or attachment to, a single device. 
The submission must compare each such component or attachment with that of a predicate
device, or must state that the predicate device lacks such a component or attachment.
2. The following information must be provided:
a. The proprietary name of the new device;
b. The generic name of the device;
c. The classification of the predicate device e.g., Class II.  Refer to 21 CFR and section
513 of the Food, Drug, and Cosmetic Act;
d. The proposed regulatory class for the new device, e.g., Class II.  (21 CFR 862-892
contains the regulatory classifications for medical devices); and
e. The panel code(s) for the device.  [If the product is not classified under the physical
medicine devices panel, identify the panel under which it is classified and provide
the panel identification code (e.g., 89 is the code for the physical medicine devices
panel)].
page 3 3. Specify whether this device:
a. Has been previously submitted to the FDA for identical or different indications; or
b. Is currently being reviewed for different indications by the same or different branch
within ODE; or
c. Has been previously cleared by the FDA for different indications.
DEVICE DESCRIPTIVE INFORMATION
Intended Use
Identify the specific intended use(s) for the subject device and the predicate device.  The new
device must have the same intended medical uses as those specified for the predicate device, to the
extent that the changes do not alter the therapeutic or diagnostic effect and do not affect safety and
effectiveness. These intended uses must be consistent with the descriptions of intended medical
uses contained within the CFR section that is applicable to the device and must identify the specific
medical conditions for which the device is indicated.  If the indication differs, you must provide a
justification as to how the change(s) do not affect safety and effectiveness.  If special labeling
claims are sought, information must be provided to support these claims. 
Device Description
1. Provide  a  written  device  description,  including  all  device  components,  accessories,
instruments, and any new features of the device.
2. Specify the relevant dimensions of the device and all possible configurations, and functions
of each device component.
3. Describe how the device works and interconnects with other components.
4. Provide engineering diagrams and/or photographs  of the device, and complete written
descriptions of the new and predicate devices.  The document must contain illustrations of
all internal and external features of both devices.  Engineering diagrams must provide the
lengths, widths, and heights of the devices and their major component parts.
5. Photographs or other illustrations, such as dimensioned drawings, must provide front, rear
and side views of the devices.
6. Specify the dimensions and weight of the device.
7. Indicate the kind of surface on which the device can be operated.
8. Specify the maximum weight bearing capacity of the device.
page 4 9. Report the results of "tiltover" tests performed laterally, posteriorly and anteriorly with a
user of maximum allowable weight and maximum allowable seat height or when standing
up (these usually apply to standup wheelchairs or wheelchairs in which the seat can be
elevated).
You  may  also  report  the  results  of  the  VA  drop  test  if  performed.  (This  is  not  a
requirement.)
10. Specify  whether  the  device  design  conformance  to  any  other  voluntary  performance
standards, e.g., ANSI/RESNA standards.
Materials
Identify the specific materials for each component any additional processing that may affect the
properties of the materials, and the voluntary standards with which the device materials will
conform.      The  information  should  also  include  a  description  of  the  material  strength  tests
performed on the frame and wheels.  The results of flame retardant tests of the upholstery materials
should be reported.
Labeling
1. Provide draft or sample package labeling, package inserts, including complete operator's
instructions,  and  required  labeling  regarding  electromagnetic  interference  (EMI)
according  to  FDA's  March  26,  1994  labeling  letter  mailed  to  wheelchair
manufacturers (copy attached).
2.  Provide the following prescription statement (both on the device itself and in the operator's
manual, and in any advertising and/or promotional materials) according to 21 CFR 801.109:
Caution: Federal law restricts this device to sale by or on the order of a practitioner
licensed by the law of the State in which he/she practices."
3. Include copies of promotional materials for the new and predicate devices.
4. Provide cleaning instructions.
Additional Information
The following specific information is required for powered devices in addition to the information
specified elsewhere in this document.
1. Specify the type of motor used.
2. The following information regarding the breaking system must be included:
a. A detailed drawing of the system with electrical schematics;
b. An explanation of how the wheelchair stops in case of an electrical brake failure;
and
c. information on the braking time and distance.
page 5 3. Report the results of the electrical safety test for the battery recharger, the flame retardant
test of the upholstery material; and the ground leakage values (max 100 A allowed).
4. Specify the number of batteries (gel or dry acid).
5. Indicate the maximum distance of travel on the fully charged battery.
6. If your device uses controlling software, you should refer to the FDA document entitled
"Reviewer  Guidance  for  Computer  Controlled  Medical  Devices  Undergoing  510(k)
Review", dated August 29, 1991.  As described in this document, you should determine and
justify the level of concern you believe to be associated with your device's software. 
Further, in accordance with this guidance, provide documentation, commensurate with the
level of concern, including: 1) System and Software Requirements & Design, 2) Software
Development, 3) Verification & Validation (V&V), 4) Test Results and Analysis, and 5)
Certification.  You must also provide a hazards analysis for the software, identifying safety
requirements for the software and system.  
Please be advised that if you provide only the minimum information highlighted in the
"510(k)  Review  Software  Documentation  Matrix",  this  may  not  assure  adequate
information to make a determination about the software.  In documenting V&V procedures
(all levels of concern), you should provide pass/fail and test completion criteria, and a
system level functional test plan.  You should refer to the sample questions provided in this
guidance and to other sources, as necessary.  You are encouraged to submit a summary of
the development life cycle in terms of how it assures traceability of the safety concerns
throughout development, and how the testing and analyses adequately demonstrate that the
software meets its functional and safety requirements.  Overall, the software documentation
provided should allow for an adequate assessment of the quality of the software design and
development, and of the level of software quality control.
  Copies  of  this  guidance  document  can  be  obtained  from  the  Division  of  Small
Manufacturers Assistance (DSMA), at 800-638-2041.
7. Specify the speed limits while in slow, normal, and high control (max 6 m.p.h. allowed).
8. Specify in degrees the maximum safe operational incline, that the device can climb safely, 
in degrees measure posteriorly, anteriorly and sideways with the center of gravity at the
highest level.
9. Specify the highest curb clearance.
10. Specify the maximum safe speed and minimum turning radius to prevent tip over during
operation.
11. Provide documented information on the electromagnetic compatibility of the device as
described in the addition to ISO EMC Draft Standard 7176-14, titled Draft ISO EMC Group
Proposal: Electromagnetic Compatibility Addition, dated April 3, 1995 (copy attached)
regarding  electromagnetic  compatibility  requirements  for  powered  wheelchairs  and
motorized scooters. 
page 6 SUBSTANTIAL EQUIVALENCE INFORMATION
1. The legally marketed predicate device with which the subject device is to be compared for
the determination of substantial equivalence must be identified.  Evidence must be provided
that the device was placed into interstate commerce for other than research uses or as part of
a plant-to-plant transfer and was actually labeled and promoted for the intended use to
which the submitter of the premarket notification is claiming substantial equivalence.  This
may be accomplished by providing copies of the firm's advertisements, catalog pages, or
other promotional material dated prior to May 28, 1976 and shipping documents such as
invoices, bills of lading, receipts showing the interstate transit of the device (for other
information which can be used to prove Pre-Amendment status contact DSMA).
Alternatively, the 510(k) number(s) of the predicate device(s) may be identified.  The
510(k) number may be obtained from the Electronic Docket (ED), an automated retrieval
system  of  the  Division  of  Small  Manufacturers  Assistance  (DSMA),  which  provides
medical device regulations, FDA talk papers and press releases, device evaluation guidance,
and the listing of all approved 510(k)s sorted by applicant name.  This 510(k) information is
located under the Product Clearance Main Menu Item # 12.  Dial (301) 594-4802 or (800)
252-1366.  For more guidance on how to assess this information, contact DSMA.  Call toll
free (800) 638-2041, (301) 443-6597, or fax (301) 443-8818.  
2. The submission should include a description of all significant similarities and differences
between the new and predicate devices.  To facilitate review, the submission should contain
a summary table which compares the two devices in terms of the intended medical uses,
functions and physical characteristics, including safety characteristics. All technological
characteristics that describe the device subject of the submission and that demonstrate the
substantial equivalence between the device and a legally marketed device must be reported.
510(K) SUMMARY OR STATEMENT
1. Provide  a  510(k)  summary  of  safety  and  effectiveness  information  in  the  premarket
notification submission upon which an equivalence determination could be based, written in
accordance with the content and format requirements that are specified in 21 CFR 807.92,
or
2.  Provide a 510(k) statement that safety and effectiveness information will be made available
to interested persons upon request.  This statement must follow the format and contain the
wording as specified in 21 CFR 807.93.
TRUTH AND ACCURACY STATEMENT
Provide a statement that all data and information submitted in the premarket notification are
truthful and accurate and that no material fact has been omitted, as required by 21 CFR
807.87(j).
page 7