Atlas FDA

IOY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Support, Arm
Device class
Class I (low risk)
Regulation
21 CFR 890.3475
Medical specialty
Physical Medicine
Flags
GMP exempt
Adverse events (MAUDE)
2014: 14 · 2016: 12 · 2020: 16 · 2021: 25 · 2022: 13 · 2023: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDateBuilder
ADJUSTABLE ARM SUPPORT (K770065)Richard F. Kronner, M.D.1977-02-02+ Add

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