The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Sonicstimu Combo Therapeutic Device.
| Device ID | K120217 |
| 510k Number | K120217 |
| Device Name: | SONICSTIMU COMBO THERAPEUTIC DEVICE |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE Shenzhen, CN 518108 |
| Contact | Kang Jian Ping |
| Correspondent | Kang Jian Ping SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE Shenzhen, CN 518108 |
| Product Code | IMG |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-24 |
| Decision Date | 2012-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237616440 | K120217 | 000 |
| 00092237621462 | K120217 | 000 |
| 80092237621475 | K120217 | 000 |
| 80092237605468 | K120217 | 000 |
| 80092237611629 | K120217 | 000 |
| 50092237615213 | K120217 | 000 |
| 50092237615220 | K120217 | 000 |
| 80092237616433 | K120217 | 000 |
| 80092237616747 | K120217 | 000 |
| 10092237617806 | K120217 | 000 |
| 10092237617813 | K120217 | 000 |
| 00092237618219 | K120217 | 000 |
| 00092237618226 | K120217 | 000 |
| 80092237618727 | K120217 | 000 |
| 80092237622090 | K120217 | 000 |