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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| Record | Firm | Date | Builder |
|---|---|---|---|
| ADJUSTABLE ARM SUPPORT (K770065) | Richard F. Kronner, M.D. | 1977-02-02 | + Add |
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