OYS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Patient Bed With Canopy/Restraints
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6760
- Medical specialty
- General Hospital
- FDA definition
- Enclosed bed canopy system used as passive restraint.
- Adverse events (MAUDE)
- 2018: 15 · 2019: 16 · 2022: 28 · 2024: 31 · 2025: 87 · 2026: 57
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| POSEY BED (K113355) | J. T. Posey Co. | 2012-05-02 |
| POSEY BED (K113357) | J. T. Posey Co. | 2012-03-21 |
| POSEY BED (K103817) | J. T. Posey Co. | 2011-04-22 |
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