K954671 is an FDA 510(k) clearance for the THE FREEDOM BED. This device is classified as a Bed, Patient Rotation, Powered (Class II - Special Controls, product code IKZ).
Submitted by Probed Medical Technologies, Inc. (Chilliwack, B.C., CA). The FDA issued a Cleared decision on April 1, 1996, 174 days after receiving the submission on October 10, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5225.
| 510(k) Number | K954671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1995 |
| Decision Date | April 01, 1996 |
| Days to Decision | 174 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 |