[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: 21CFR890.3910]

[Page 495]
 
                        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. 890.3910  Wheelchair accessory.

    (a) Identification. A wheelchair accessory is a device intended for 
medical purposes that is sold separately from a wheelchair and is 
intended to meet the specific needs of a patient who uses a wheelchair. 
Examples of wheelchair accessories include but are not limited to the 
following: armboard, lapboard, pusher cuff, crutch and cane holder, 
overhead suspension sling, head and trunk support, and blanket and leg 
rest strap.
    (b) Classification. Class I (general controls). If the device is not 
intended for use as a protective restraint as defined in Sec. 880.6760 
of this chapter, it is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 890.9. The device is also exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with the 
exception of Sec. 820.180, regarding general requirements concerning 
records, and Sec. 820.198, regarding complaint files.

[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001]