KID
7 FDA 510(k) clearances · Product code
42 daysmedian time to decision
143 days90th percentile
7clearances measured
FDA profile
- Official device name
- Restraint, Wheelchair, Non-Protective
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3910
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 4 · 1993: 4 · 1995: 2
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 |
|---|---|---|
| WHEELCHAIR BELT (K963479) | Deroyal Industries, Inc. | 1997-01-24 |
| MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (K963480) | Deroyal Industries, Inc. | 1997-01-22 |
| PONCHO VEST RESTRAINT (K963475) | Deroyal Industries, Inc. | 1997-01-22 |
| SUPPORT VEST (K963459) | Skil-Care Corp. | 1996-10-15 |
| SAFETY PONCHO/SHOULDER STRAP PONCHO (K963461) | Skil-Care Corp. | 1996-10-11 |
| SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (K963455) | Skil-Care Corp. | 1996-10-08 |
| ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (K802603) | Jefferson Industries, Inc. | 1980-11-12 |
Track KID automatically
Every clearance here is in the API, with alerts when new ones post.