K830426 is an FDA 510(k) clearance for the INFLATABLE INVALID RING. This device is classified as a Cushion, Flotation (Class I — General Controls, product code KIC).
Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983, 78 days after receiving the submission on February 9, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.
| 510(k) Number | K830426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1983 |
| Decision Date | April 28, 1983 |
| Days to Decision | 78 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 |