The following data is part of a premarket notification filed by Dongguan Bohuikang Technology Co.,ltd with the FDA for Tens&ems Stimulator (model: Kres100d, Kres1010, Kres1020, Kres1080).
| Device ID | K213788 |
| 510k Number | K213788 |
| Device Name: | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Dongguan Bohuikang Technology Co.,Ltd 5th Floor,No 5, Second Street,Huaide Shui Xiang New Strict, Humen Town Dongguan, CN 523165 |
| Contact | Rihua Meng |
| Correspondent | Jett Lee Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN 510000 |
| Product Code | NUH |
| Subsequent Product Code | IPF |
| Subsequent Product Code | NGX |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-05-06 |