K092627 is an FDA 510(k) clearance for the CT2011 SONICSTIMU PAIN RELIEF 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, Guangdong, CN). The FDA issued a Cleared decision on January 14, 2010, 141 days after receiving the submission on August 26, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5860.
| 510(k) Number | K092627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2009 |
| Decision Date | January 14, 2010 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| 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 |