IMP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cushion, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3920
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2002: 3 · 2004: 3 · 2014: 6 · 2015: 17 · 2016: 15 · 2023: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ULTIMA WHEELCHAIR CUSHION (K890653) | Clark Pillow Co., Inc. | 1989-02-28 |
| EDCOOL AND EDCOOL JR. INSTANT COLD PACK (K871006) | Advantage Credit Services, Inc. | 1987-03-25 |
Track IMP automatically
Every clearance here is in the API, with alerts when new ones post.