K970636 is an FDA 510(k) clearance for the TOTALCARE., MODULAR THERAPY SYSTEM (MTS). This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on August 26, 1997, 187 days after receiving the submission on February 20, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K970636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1997 |
| Decision Date | August 26, 1997 |
| Days to Decision | 187 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 |