---
kind: "section"
citation: "21 C.F.R. § 890.3910"
title: "21"
number: "890.3910"
heading: "Wheelchair accessory."
url: "https://uscodex.org/cfr/21/890.3910"
---

# §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 [§ 880.6760](/cfr/21/880.6760.md) of this chapter, it is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 890.9](/cfr/21/890.9.md). The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.

### Amendments

[61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025]