# K963452: Medline Zipper Sleeved Vest

- Pathway: 510(k) (Traditional)
- Applicant: Medline
- Decided: Oct 18, 1996 after 45 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
Medline Zippered Sleeved Vest Restraints may be used either in a bed or wheelchair. They are intended for use with patients or residents that need a “gentle reminder” for the patient to stay in their bed or wheelchair. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.

Source page: https://510kreport.com/device/K963452
Methodology: https://510kreport.com/methodology