21 CFR 890.3920 — Armrest, Wheelchair
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3920
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IML | Armrest, Wheelchair | 1 | 0 | |
| IMM | Footrest, Wheelchair | 1 | 2 | |
| IMN | Climber, Curb, Wheelchair | 1 | 0 | |
| IMO | Handrim, Wheelchair | 1 | 0 | |
| IMP | Cushion, Wheelchair | 1 | 2 | |
| IMQ | Attachment, Narrowing, Wheelchair | 1 | 0 | |
| IMR | Device, Anti-Tip, Wheelchair | 1 | 0 | |
| IMW | Brake, Extension, Wheelchair | 1 | 0 | |
| INA | Hill Holder, Wheelchair | 1 | 0 | |
| INB | Attachment, Commode, Wheelchair | 1 | 0 | |
| IQB | Belt, Wheelchair | 1 | 2 | |
| KNN | Components, Wheelchair | 1 | 64 | |
| LFF | Unit, Activation, Breath Control | 1 | 1 |
