(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 requirements of the quality system regulation 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]