K120217 is an FDA 510(k) clearance for the SONICSTIMU COMBO THERAPEUTIC DEVICE. This device is classified as a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMG).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 21, 2012, 302 days after receiving the submission on January 24, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5860.
| 510(k) Number | K120217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2012 |
| Decision Date | November 21, 2012 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5860 |