INF
5 FDA 510(k) clearances · Product code
34 daysmedian time to decision
164 days90th percentile
5clearances measured
FDA profile
- Official device name
- Scale, Platform, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3940
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1993: 1 · 2002: 1
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 |
|---|---|---|
| U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (K924441) | U.S. Medical Corp. | 1993-02-12 |
| ACME MODEL 8500 WHEELCHAIR SCALE (K910055) | Acme Medical Scale Co. | 1991-01-14 |
| ULTRAFLOTATION MEDICAL WHEELCHAIR (K884908) | Medical Flotation Systems, Inc. | 1988-12-27 |
| AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) (K871391) | Amigo Sales, Inc. | 1987-05-06 |
| WHEEL'N WEIGH (K760327) | Acme Medical Scale Co. | 1976-10-20 |
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Every clearance here is in the API, with alerts when new ones post.