Atlas FDA

IPM

6 FDA 510(k) clearances · Product code

20 daysmedian time to decision
90 days90th percentile
6clearances measured

FDA profile

Official device name
Cover, Limb
Device class
Class I (low risk)
Regulation
21 CFR 890.3025
Medical specialty
Physical Medicine
Flags
GMP exempt
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RecordFirmDate
ELASTO-GEL CAST & SPLINT PADS (K872488)Southwest Technologies, Inc.1987-09-21
COVER LIMB (K823399)Orthopedic Systems, Inc.1982-11-29
COVER, LIMB (K801627)The Owenby Co.1980-07-28
LIMB COVER (K780905)Hydro-Med Products, Inc.1978-08-14
HEAVY FOAM HEEL & ELBOW PROTECTORS (K770223)Robert R. Moore1977-02-23
FOAM SLIPPERS (K761114)Fred Sammons, Inc.1976-12-02

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