# K963475: Poncho Vest Restraint

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Jan 22, 1997 after 141 days
- Product code: KID (Restraint, Wheelchair, Non-Protective)
- Device class: 1
- Regulation: 21 CFR 890.3910
- 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) J.T. Posey Company: named in the summary without a submission number
- (no number) DeRoyal Industries, Inc.: named in the summary without a submission number

## Indications for use
The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

Source page: https://510kreport.com/device/K963475
Methodology: https://510kreport.com/methodology