Atlas FDA

ILE

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Sling, Arm, Overhead Supported
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
Flags
GMP exempt
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RecordFirmDate
OB HELP ARM (K830842)Lic-Orthion1983-04-05
OVERHEAD ARM SLINGS (K823811)Danek Medical, Inc.1983-01-14
OB HELP ARM (K823152)Orthion Corp.1982-11-05

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