# K971536: Restraints (Vests and Jackets)

- Pathway: 510(k) (Traditional)
- Applicant: E.M. Adams Co., Inc.
- Decided: Jul 1, 1997 after 64 days
- Product code: FMQ (Restraint, Protective)
- 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indicated use of these Vests and Jackets is to be used as a mild restraint. To help prevent the patient from falling, sliding or getting out of bed. The Vests and Jackets can be used in a hospital bed, wheelchair or geriatric chair. These Vests and Jackets should not be used on violent patients.

Source page: https://510kreport.com/device/K971536
Methodology: https://510kreport.com/methodology