K951001 is an FDA 510(k) clearance for the FLEXICAIR EXLIPSE. 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 June 27, 1995, 116 days after receiving the submission on March 3, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K951001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1995 |
| Decision Date | June 27, 1995 |
| Days to Decision | 116 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 |