# K110377: Protective Restraint

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Tech Intl. Corp.
- Decided: Apr 25, 2011 after 75 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 K963413 (1996). 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)
- K963413: Multiple Limb Holders, J. T. Posey Co. (1996) Summary page 1.

## Indications for use
Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

Source page: https://510kreport.com/device/K110377
Methodology: https://510kreport.com/methodology