510(k) K963476 ยท FMQ Restraint, Protective
DISPOSABLE LIMB HOLDER
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Jan 22, 1997 |
| Received | Sep 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2014 | DeRoyal Industries Inc DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017
Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/o Terminated |
FMQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.