K963479 is an FDA 510(k) clearance for the WHEELCHAIR BELT. This device is classified as a Restraint, Wheelchair, Non-protective (Class I - General Controls, product code KID).
Submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 24, 1997, 143 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 | K963479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1996 |
| Decision Date | January 24, 1997 |
| Days to Decision | 143 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 |