# K963450: Safety Vest/Shoulder Strap Vest/Economy Safety Vest

- Pathway: 510(k) (Traditional)
- Applicant: Skil-Care Corp.
- Decided: Oct 7, 1996 after 34 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) Safety Vest: named in the summary without a submission number
- (no number) Economy Safety Vest: named in the summary without a submission number
- (no number) Vest with Shoulder Straps: named in the summary without a submission number

## Indications for use
Safety Vest is intended for patients who require restraint while in the wheelchair or bed. Economy Safety Vest is intended for patients who require restraint while in the wheelchair or bed. Vest with Shoulder Straps is intended for patients who require restraint and posture support while in the wheelchair.

Source page: https://510kreport.com/device/K963450
Methodology: https://510kreport.com/methodology