K131899 is an FDA 510(k) clearance for the SW-THERM. This device is classified as a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMJ).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 14, 2014, 262 days after receiving the submission on June 25, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K131899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2013 |
| Decision Date | March 14, 2014 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |