# K963906: Patient Restraints

- Pathway: 510(k) (Traditional)
- Applicant: Safety Intl., Inc.
- Decided: Dec 2, 1996 after 63 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
Longest line of descent: 1 generation back to K760618 (1976). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850470: Bed Products, Abco Dealers, Inc. (1985) Summary page 1.
- K780232: Restraint, Protective, Biomet, Inc. (1978) Summary page 1.
- K760618: Patient Restraint, Encompass Group, LLC (1976) Summary page 1.
- K812473: Head Protector, Maddak, Inc. (1981) Summary page 1.
- K771629: Hand Restraint, Medical Restraints, Inc. (1977) Summary page 1.
- (no number) Morrison Medical Products Restraint, Protective: named in the summary without a submission number

## Indications for use
The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.

Source page: https://510kreport.com/device/K963906
Methodology: https://510kreport.com/methodology