Atlas FDA

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