# K982783: Vail 1000 Enclosed Bed

- Pathway: 510(k) (Traditional)
- Applicant: Vail Products, Inc.
- Decided: Oct 5, 1998 after 59 days
- Product code: FNL (Bed, Ac-Powered Adjustable Hospital)
- Device class: 2
- Regulation: 21 CFR 880.5100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- May 6, 2005 · Not classified · Z-0862-05: Risk of patient entrapment, may result in serious injury or death.

## Indications for use
The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unassisted

Source page: https://510kreport.com/device/K982783
Methodology: https://510kreport.com/methodology