# K963485: Silicone Rubber Cuff/Disposable Fleece Liner's Web Torso Resraint,Nyon Limb Holder,Vinyl Limb Holder,Nylon Bed Restrains

- Pathway: 510(k) (Traditional)
- Applicant: Humane Restraint, Inc.
- Decided: Nov 22, 1996 after 80 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) Fleece Liner: named in the summary without a submission number
- (no number) Silicone Rubber Cuff: named in the summary without a submission number
- (no number) Web Torso Restraint: named in the summary without a submission number
- (no number) Nylon Limb Holder: named in the summary without a submission number
- (no number) Vinyl Limb Holder: named in the summary without a submission number
- (no number) Nylon Bed Restraint (wrist): named in the summary without a submission number
- (no number) Nylon Torso Restraint: named in the summary without a submission number
- (no number) Nylon Transporter: named in the summary without a submission number

## Indications for use
Other than the fleece liner, all devices are intended to limit movement of severely agitated persons who may cause harm to themselves or to others if not restrained. The fleece liner is an accessory to reduce challing when used with the silicone rubber cuff. Where lucks are a part of the device, they are for the purpose of lessening the chance of unauthorized release.

Source page: https://510kreport.com/device/K963485
Methodology: https://510kreport.com/methodology