[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3920]

[Page 495-496]
 
                        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

[[Page 496]]

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 (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 
FR 38817, July 25, 2001]