K142976 is an FDA 510(k) clearance for the UltraTENS. This device is classified as a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMI).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 26, 2015, 316 days after receiving the submission on October 14, 2014.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K142976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2014 |
| Decision Date | August 26, 2015 |
| Days to Decision | 316 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |