[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3920]

[Page 486]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart D--Physical Medicine Prosthetic Devices
 
Sec. 890.3920  Wheelchair component.

    (a) Identification. A wheelchair component is a device intended for 
medical purposes that is generally sold as an integral part of a 
wheelchair, but may also be sold separately as a replacement part. 
Examples of wheelchair components are the following: Armrest, narrowing 
attachment, belt, extension brake, curb climber, cushion, antitip 
device, footrest, handrim, hill holder, leg rest, heel loops, and toe 
loops.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994]