Atlas FDA

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.
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RecordFirmDate
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

Track INF automatically

Every clearance here is in the API, with alerts when new ones post.