K963431 is an FDA 510(k) clearance for the POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER. This device is classified as a Restraint, Protective (Class I - General Controls, product code FMQ).
Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on November 6, 1996, 68 days after receiving the submission on August 30, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6760.
| 510(k) Number | K963431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1996 |
| Decision Date | November 06, 1996 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMQ — Restraint, Protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6760 |