KID · Restraint, Wheelchair, Non-Protective
Physical Medicine · 21 CFR 890.3910 · Class 1
Overview
| Product Code | KID |
|---|---|
| Device Name | Restraint, Wheelchair, Non-Protective |
| Regulation | 21 CFR 890.3910 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
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.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963479 | WHEELCHAIR BELT | Deroyal Industries, Inc. | Jan 24, 1997 | SESE |
| K963480 | MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER | Deroyal Industries, Inc. | Jan 22, 1997 | SESE |
| K963475 | PONCHO VEST RESTRAINT | Deroyal Industries, Inc. | Jan 22, 1997 | SESE |
| K963459 | SUPPORT VEST | Skil-Care Corp. | Oct 15, 1996 | SESE |
| K963461 | SAFETY PONCHO/SHOULDER STRAP PONCHO | Skil-Care Corp. | Oct 11, 1996 | SESE |
| K963455 | SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL | Skil-Care Corp. | Oct 8, 1996 | SESE |
| K802603 | ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION | Jefferson Industries, Inc. | Nov 12, 1980 | SESE |
Top Applicants
- Deroyal Industries, Inc. — 3 clearances
- Skil-Care Corp. — 3 clearances
- Jefferson Industries, Inc. — 1 clearance
