The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co., Ltd. with the FDA for Combo Stimulator Mt9000, Combo Stimulator Lt7102, Tens Stimulator Intensity 10.
| Device ID | K171978 |
| 510k Number | K171978 |
| Device Name: | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Contact | Siping Yuan |
| Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co., Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-10-02 |
| Summary: | summary |