K813225 is an FDA 510(k) clearance for the GEL FLOTATION CUSHION. This device is classified as a Cushion, Flotation (Class I - General Controls, product code KIC).
Submitted by Jefferson Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981, 23 days after receiving the submission on November 10, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.
| 510(k) Number | K813225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1981 |
| Decision Date | December 03, 1981 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KIC — Cushion, Flotation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3175 |