K972111 is an FDA 510(k) clearance for the RUMORS DYNAMIC AIR THERAPY UNIT. This device is classified as a Bed, Patient Rotation, Powered (Class II - Special Controls, product code IKZ).
Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on February 2, 1998, 242 days after receiving the submission on June 5, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5225.
| 510(k) Number | K972111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1997 |
| Decision Date | February 02, 1998 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IKZ — Bed, Patient Rotation, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5225 |