# K971948: Patient Restraint

- Pathway: 510(k) (Traditional)
- Applicant: E.M. Adams Co., Inc.
- Decided: Aug 6, 1997 after 70 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indicated use of these Limb Holders, Mitts and Elbow Splints are to be used as a medical restraint to help prevent patient from pulling and disconnecting other medical devices that are being used in their treatment. These Limb Holders, Mitts and Elbow Splints are intended to be used on hospital beds, wheel chairs, and geriatric chairs. These devices should not be used on extremely violent patients.

Source page: https://510kreport.com/device/K971948
Methodology: https://510kreport.com/methodology