K970295 is an FDA 510(k) clearance for the FLEXICAIR EXLIPSE PLUS. This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).
Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on May 16, 1997, 109 days after receiving the submission on January 27, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K970295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1997 |
| Decision Date | May 16, 1997 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5170 |