Submission Details
| 510(k) Number | K970636 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
Aug 1997
Decision
187d
Days
Class 2
Risk
About This 510(k) Submission
K970636 is an FDA 510(k) clearance for the TOTALCARE., MODULAR THERAPY SYSTEM (MTS), 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 review panel. Regulated under 21 CFR 890.5170.
Device Classification
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5170 |
Manufacturer
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