21 CFR 890.3910 — Support, Head And Trunk, Wheelchair
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3910
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.
Classification Rationale
Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 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 § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IMS | Support, Head And Trunk, Wheelchair | 1 | 0 | |
| IMX | Board, Lap, Wheelchair | 1 | 2 | |
| IMY | Armboard, Wheelchair | 1 | 0 | |
| IMZ | Holder, Crutch And Cane, Wheelchair | 1 | 0 | |
| INC | Cuff, Pusher, Wheelchair | 1 | 0 | |
| INE | Sling, Overhead Suspension, Wheelchair | 1 | 1 | |
| KID | Restraint, Wheelchair, Non-Protective | 1 | 7 | |
| KNO | Accessories, Wheelchair | 1 | 35 |
