# K972123: Protective Restraint Models #302,440,750,850,AND905

- Pathway: 510(k) (Traditional)
- Applicant: Smith
- Decided: Jul 25, 1997 after 50 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 Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K972123
Methodology: https://510kreport.com/methodology