# K963435: Economy Safety Vest Restraint, Shoulder Tie Safety Vest/Safety Vest Restraint, Heavy Duty Vest Restraint, Mesh Safety VE

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Patient Care Division
- Decided: Nov 6, 1996 after 68 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 Zimmer line of restraints is intended for restiess, confused, eiderly, or unsteady patients. They help prevent such patients from injuring themselives or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances. Finally, these restraints are labeled with the prescription legend, and thus, should only be used on the order of a physician.

Source page: https://510kreport.com/device/K963435
Methodology: https://510kreport.com/methodology