The following data is part of a premarket notification filed by Shenzhen Conree Technology Co.,ltd with the FDA for Mini Tens Device (model: Kres102), Tens &ems Device (model: Kres100b).
| Device ID | K172933 |
| 510k Number | K172933 |
| Device Name: | Mini TENS DEVICE (Model: KRES102), TENS &EMS DEVICE (Model: KRES100B) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Shenzhen Conree Technology Co.,Ltd Room 210, No 2 Industry Building, Hao Shi Road Hao San Shang Xing Inds. Park Shenzhen, CN |
| Contact | Rihua Meng |
| Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City LuoGang District Guangzhou, CN |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | NUH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970890321001 | K172933 | 000 |