# K963430: Protective Restraint (Vest Restraint)

- Pathway: 510(k) (Traditional)
- Applicant: Kenad SG Medical, Inc.
- Decided: Nov 22, 1996 after 84 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 K823816 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823816: Wheelchair Patient Restraints, Danek Medical, Inc. (1983). Our OCR of the scanned summary read K823815, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Danek Medical, Inc. Vest Restraints”.

## Indications for use
Kenad Vest Restraints are indicated for medical purposes where patient movement must be limited to the extent necessary for treatment, examination, protection of the patient or others, or posture control.

Source page: https://510kreport.com/device/K963430
Methodology: https://510kreport.com/methodology