The following data is part of a premarket notification filed by Hong Qiangxing (shen Zhen) Electronics Limited with the FDA for Sunmas Tens & Pms (model Sm9187, Sm9180l, Sm9180s).
| Device ID | K190009 |
| 510k Number | K190009 |
| Device Name: | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District Shenzhen, CN 518126 |
| Contact | Xu Jianhua |
| 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 | 2019-01-03 |
| Decision Date | 2019-12-02 |