K963480 is an FDA 510(k) clearance for the MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER. This device is classified as a Restraint, Wheelchair, Non-protective (Class I - General Controls, product code KID).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on January 22, 1997, 141 days after receiving the submission on September 3, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3910.
| 510(k) Number | K963480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1996 |
| Decision Date | January 22, 1997 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | KID — Restraint, Wheelchair, Non-protective |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3910 |