K770170 is an FDA 510(k) clearance for the MADDATHERM PARAFFIN BATH. This device is classified as a Bath, Paraffin (Class II - Special Controls, product code IMC).
Submitted by Techhnilab Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977, 3 days after receiving the submission on January 25, 1977.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5110.
| 510(k) Number | K770170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1977 |
| Decision Date | January 28, 1977 |
| Days to Decision | 3 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMC — Bath, Paraffin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5110 |