# K962429: Safety Vest

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Sep 18, 1996 after 86 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 its predicate without a number.
- (no number) Posey Waist & Chest Vest: named in the summary without a submission number
- (no number) Posey Criss-Cross Vest: named in the summary without a submission number
- (no number) Posey-Van Pelt Limb Holder: named in the summary without a submission number
- (no number) Posey Economy Limb Holder: named in the summary without a submission number

## Indications for use
The Johnson & Johnson Safety Vests are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them. These products can be used in restraining patients to a bed or chair. The Johnson & Johnson Limb Holders are designed to protect patients that are at risk of self injury or interruption of medical care by restraining them. These products can be used in restraining patients to a bed or chair.

Source page: https://510kreport.com/device/K962429
Methodology: https://510kreport.com/methodology