IMP · Cushion, Wheelchair
Physical Medicine · 21 CFR 890.3920 · Class 1
Overview
| Product Code | IMP |
|---|---|
| Device Name | Cushion, Wheelchair |
| Regulation | 21 CFR 890.3920 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890653 | ULTIMA WHEELCHAIR CUSHION | Clark Pillow Co., Inc. | Feb 28, 1989 | SESE |
| K871006 | EDCOOL AND EDCOOL JR. INSTANT COLD PACK | Advantage Credit Services, Inc. | Mar 25, 1987 | SESE |
Top Applicants
- Advantage Credit Services, Inc. — 1 clearance
- Clark Pillow Co., Inc. — 1 clearance
