K911843 is an FDA 510(k) clearance for the ZERO-G(TM) GEL/FOAM MATTRESS TOPPER. This device is classified as a Cushion, Flotation (Class I - General Controls, product code KIC).
Submitted by Steridyne Corp. (Riviera Beach, US). The FDA issued a Cleared decision on May 30, 1991, 35 days after receiving the submission on April 25, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3175.
| 510(k) Number | K911843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1991 |
| Decision Date | May 30, 1991 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | KIC — Cushion, Flotation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3175 |