K863047 is an FDA 510(k) clearance for the FLEXICAIR. This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).
Submitted by Ssi Medical Services, Inc. (Chicago, US). The FDA issued a Cleared decision on September 5, 1986, 24 days after receiving the submission on August 12, 1986.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K863047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1986 |
| Decision Date | September 05, 1986 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5170 |