# K962963: Checkmate Ankle Restraint System

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Oct 24, 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) Checkmate Ankle Restraint System: named in the summary without a submission number

## Indications for use
The Checkmate Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a bed or gurney. The Checkmate Ankle Restraint System is intended to secure the patient’s ankles by keeping them in a fixed position.

Source page: https://510kreport.com/device/K962963
Methodology: https://510kreport.com/methodology