K914851 is an FDA 510(k) clearance for the CLA-1400 SYSTEM. This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).
Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on November 13, 1991, 16 days after receiving the submission on October 28, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K914851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1991 |
| Decision Date | November 13, 1991 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5170 |