# K971742: Depuy Orthotech Heavy Duty Vest Restraint

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jul 24, 1997 after 73 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
Longest line of descent: 1 generation back to K963393 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963393: Mesh Vest Restraint with Sleeves Wrist/Ankle Restraint, Depuy, Inc. (1996) Summary page 1.
- (no number) Zimmer Heavy Duty Vest Restraint: named in the summary without a submission number

## Indications for use
The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to life-threatening falls, (b) may be suicidal, or (c) are aggressive.

Source page: https://510kreport.com/device/K971742
Methodology: https://510kreport.com/methodology