The following data is part of a premarket notification filed by Minghuangda Electronic Co., Ltd with the FDA for Mhd Tens.
| Device ID | K190115 |
| 510k Number | K190115 |
| Device Name: | MHD TENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | MingHuangDa Electronic Co., Ltd Floor6, Building A, Taixinglong Industrial Park Hezhou Village, Xixiang Town Baoan District, Shenzhen, CN 518100 |
| Contact | Zhang Guixiang |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road Songjiang Area Shanghai, CN 201613 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-24 |
| Decision Date | 2019-06-19 |