K801217 is an FDA 510(k) clearance for the SKIL-CARE GEL WEDGE, FLOTATION PAD. This device is classified as a Cushion, Flotation (Class I - General Controls, product code KIC).
Submitted by Skil-Care Corp. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980, 9 days after receiving the submission on May 21, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.
| 510(k) Number | K801217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1980 |
| Decision Date | May 30, 1980 |
| Days to Decision | 9 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 |