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 |