# K963492: Protective Restraint

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew Donjoy, Inc.
- Decided: Nov 12, 1996 after 70 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. The FDA summary names no predicate by number.

## Indications for use
The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are intended for use to assist cooperative patients who require minimum support in wheelchair.

Source page: https://510kreport.com/device/K963492
Methodology: https://510kreport.com/methodology