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 (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 § 890.9.

Code of Federal Regulations

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

CFR

890.3920—Wheelchair component.

Code of Federal Regulations