# K963431: Polyester Pil Wrist/Ankle Restraint/Wrist Restraint Universal/Soft Flannel Wrist/Ankle Restraint/Foam Limb Holder

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- 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 its predicate without a number.
- (no number) Foam Limb Holder w/Quick Release Buckle: named in the summary without a submission number
- (no number) Polyester Pile Wrist/Ankle Restraint: named in the summary without a submission number
- (no number) Soft Flannel Wrist/Ankle Restraint: named in the summary without a submission number
- (no number) Wrist Restraint, Universal: named in the summary without a submission number

## Indications for use
The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves 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.”

Source page: https://510kreport.com/device/K963431
Methodology: https://510kreport.com/methodology