# K113355: Posey Bed

- Pathway: 510(k) (Traditional)
- Applicant: J. T. Posey Co.
- Decided: May 2, 2012 after 170 days
- Product code: OYS (Patient Bed With Canopy/Restraints)
- Device class: 1
- Regulation: 21 CFR 880.6760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963701 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103817: Posey Bed, J. T. Posey Co. (2011) Summary page 1.
- K963701: Soma Safe Enclosure, Nova Technology Corp. (1997) Summary page 1.

## Indications for use
The Posey Bed 8040/8060 is an A-Frame canopy system. When attached to a compatible commercially available hospital bed (not included) the 8040/8060 is designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit. The Posey Bed 8040/8060 is a less restrictive alternative to physical restraints such as belts, vests, or jackets for patients at least 46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8040/8060 is a restraint, and must be prescribed by a licensed physician that includes Rx use in the home environment.

Source page: https://510kreport.com/device/K113355
Methodology: https://510kreport.com/methodology