Product code OYS— General Hospital

POSEY BED

Classification name: Patient Bed With Canopy/Restraints
Device class: Class 1
Regulation: 21 CFR 880.6760
Advisory panel: General Hospital
Total cleared: 3
First cleared: 2011-04-22
Most recent: 2012-05-02

FDA classification definition

“Enclosed bed canopy system used as passive restraint.”
— U.S. Food and Drug Administration, device classification record for product code OYS under 21 CFR 880.6760, via openFDA

Market context for product code OYS

FDA has cleared 3 devices under product code OYS between 2011 and 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20122 clearances
20111 clearance

Top applicants under product code OYS

J. T. Posey Co.3 clearances

Adverse events under product code OYS

product code OYS

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OYS

K113355 — POSEY BEDJ. T. Posey Co.·2012-05-02
K113357 — POSEY BEDJ. T. Posey Co.·2012-03-21
K103817 — POSEY BEDJ. T. Posey Co.·2011-04-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.