C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 890—PHYSICAL MEDICINE DEVICES › Subpart D—Physical Medicine Prosthetic Devices

21 C.F.R. § 890.3920

Wheelchair component

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(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.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, 2001]
Notes of Decisions
Cited in 1 case, 2012–2012 · leading case: Smith v. Phoenix Seating Sys., LLC, 894 F. Supp. 2d 1088 (S.D. Ill. 2012).
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Smith v. Phoenix Seating Sys., LLC, 894 F. Supp. 2d 1088 (S.D. Ill. 2012). · cites it 4× “3910 and thus “exempt from the current good manufacturing practice requirements of the quality system regulation in part 820,” or as plaintiffs argue, a “wheelchair component” under 21 C.F.R. § 890.3920 and thus not exempt from the current good manufacturing practice…”
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