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
EXERCISE EQUIPMENT
July 26, 1995
(reformatted 12/19/97)
This guidance document may contain references to addresses and telephone numbers that
are now obsolete.  The following contact information is to be used instead:
 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.
 For questions regarding the use or interpretation of this guidance, contact the
Restorative Devices Branch at 301-594-1296.
 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.
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 890.1925 (Isokinetic Testing and
Evaluation  System),  21  CFR  890.5360  (Measuring  Exercise  Equipment),  21  CFR  890.5380
(Powered Exercise Equipment) or 21 CFR 890.5410 (Powered Finger Exerciser) should follow the
format below and must contain all specified information that is pertinent to the device.  (See 21
CFR 890.87 and 807.90)
ADMINISTRATIVE INFORMATION
1. Provide the name, address, phone and fax number 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.
4. Identify whether confidentiality is requested.  Requests for confidentiality must contain all
information specified in 21 CFR 807.95(b).
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 (trade) name of the new device;
b. The generic (common or usual) 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,  i.e.,  Class  II  (performance
standards).  (21 CFR 862-892 contains the regulatory classifications for medical
devices); and
page 3 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)].  See HHS Publication Number FDA 91-4246 (Classification Names for
Medical Devices and In Vitro Diagnostic Products) for guidance.  The classification
name(s) and number(s) should include one or more of the following:
Classification Name Number
Bars, parallel, powered 89IRR
Ergometer, treadmill 89BYQ
Exerciser, finger, powered 89JFA
Exerciser, measuring 89ISD
Exerciser, passive, measuring 89ISC
Exerciser, powered 89BXB
System, isokinetic testing and measuring 89IKK
Treadmill, powered 89IOL
f. The number of the regulation(s) that classifies the device into Class II and type of
device specified in the regulation.  This shall include one or more of the following:
Regulation Number   Device Type
21 CFR 890.1925 Isokinetic Testing and Evaluation System
21 CFR 890.5360 Measuring Exercise Equipment
21 CFR 890.5380 Powered Exercise Equipment
21 CFR 890.5410 Powered Finger Exerciser
3. Specify whether this device:
a. Has been previously submitted to the FDA for identical or different indications;
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),  including  the  specific  diagnostic  and/or  therapeutic
indications, 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
page 4 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. 
Identify all available and intended motions, and the muscles and/or joints to be exercised.  These
intended uses should be clearly identified in the labeling.
Note that FDA regulates exercise equipment only if the equipment is intended to be used for
medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct
treatment for obesity.  FDA does not regulate exercise equipment intended only for general physical
conditioning and/or for the development of athletic abilities in individuals who lack physical
impairment.  Therefore, it is not necessary to notify FDA of an intent to market a device if it will
not be labeled or promoted for medical uses.  However, FDA will regulate the equipment and may
require premarket notification if any promotional material appears which makes medical claims
after marketing begins.
Device Description
1. Provide a written device description (e.g., mechanical, electrical, materials considerations),
specifically including any measuring systems/components,  describing how they interface
the device, and any new features of the device.
2. Identify the relevant dimensions of the device and all possible configurations.
3. Also, identify all exercise functions, and if applicable, all measuring functions of the new
device.
4. Provide  engineering  drawings  and/or  photographs  of  the  device,  and  provide  circuit
diagrams for novel or complex electrical components or systems.  Also provide illustrations
or photographs and written descriptions of the predicate device.
5. Provide a hazards analysis for the new device, identifying the device's safety features. 
6. For each intended motion, the range of motion through which the intended muscles and/or
joints are exercised and the range of forces exerted should be provided.  For powered
exercise equipment, the speed by which the intended muscles and or joints will be exercised
should also be provided. 
If  available,  provide  this  information  for  the  predicate  device  (for  documentation  of
substantial equivalence as discussed in Substantial Equivalence section below).
Performance data must  be  provided  for  all  clinical  measuring  functions.    The  testing
methodology and conclusions of the testing should be described. 
page 5 Materials
Identify the specific materials for each component, any additional processing that may affect the
material properties and the voluntary standards with which the device materials will conform.
Labeling
1. Provide draft or sample package labeling, package inserts, including complete operator's
and maintenance instructions for the new device.
2. Include copies of promotional materials for the new and predicate devices.
3. Depending on the device's indication, the following prescription statement may be required
(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."
Additional Information
1.  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.  
2. 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.
3. Provide a specification and test reference of the ground leakage current of the new device  if
it contains electrical components.  Note that the ground leakage current must be less than
100 microamperes.
page 6 4. For powered exercise devices, a photograph or illustration should be  provided clearly
identifying  the  location  of  the  device's  safety  switch  by  which  the  user  can  stop  the
operation of the new device.  Discuss/illustrate how the safety switch will be identified and
easily accessible to the user.
5. Specify all potentially flammable materials used with the new device and whether these
materials have been tested in conformance with some standard (specify) or provide the
results of testing of the fire-retarding properties of these materials.
6. Provide a statement as to whether the device meets any applicable electrical or mechanical
safety standards.
7. Electromagnetic compatibility (EMC): 
You should be aware that the issue of EMC may need to be addressed in future applications
for this type of device.  Such a requirement will be announced in advance.
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.  In addition, the
submission should provide a written summary as to the substantial equivalence of the new
device compared to the predicate in terms of safety and effectiveness considerations.
page 7 510(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.
TRUTHFUL AND ACCURATE 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 8 Attachment
PREMARKET NOTIFICATION EXEMPT DEVICES
Medical devices described within 21 CFR 890.5350 (Exercise Component) and 21 CFR 890.5370
(Nonmeasuring Exercise Equipment) are classified into Class I (general controls) and are exempt
from the premarket notification procedures in Subpart E of Part 807 of 21 CFR.  FDA therefore
does not require 510(k) premarket notifications for these devices.  Nevertheless, they are still
subject to general controls.
Persons  requesting  FDA  to  determine  whether  it  is  necessary  to  submit  a  510(k)  premarket
notification for exercise equipment that might be regulated under 21 CFR 890.5350 or 21 CFR
890.5370 should supply:
1. A complete description of the device.
2. Provide  engineering  drawings  and/or  photographs  of  the  device,  and  provide  circuit
diagrams for novel or complex electrical components or systems.  Also provide illustrations
or photographs and written descriptions of the predicate device.
3. Identify the specific intended use(s), including the specific diagnostic indications, 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. 
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.
Note that FDA regulates exercise equipment only if the equipment is intended to be used for
medical purposes, such as to redevelop muscles or restore motion to joints or for use as an
adjunct treatment for obesity.  FDA does not regulate exercise equipment intended only for
general physical conditioning and/or for the development of athletic abilities in individuals
who lack physical impairment.  Therefore, it is not necessary to notify FDA of an intent to
market a device if it will not be labeled or promoted for medical uses.  However, FDA will
regulate the equipment and may require premarket notification if any promotional material
appears which makes medical claims after marketing begins.
4. Provide a copy of the labeling and promotional material for the device.   All medical claims
in this material must be consistent with the medical purposes described in the cited CFR
section.  Also, provide a copy of promotional material for a similar marketed device.
5. Performance  data must  be  provided  for  all  clinical  measuring  functions.    The  testing
methodology and conclusions of the testing, should be described. 
page 9