The following data is part of a premarket notification filed by Hong Qiangxing (shen Zhen) Electronics Limited with the FDA for Tens & Pms (model: Sm9126).
| Device ID | K220150 |
| 510k Number | K220150 |
| Device Name: | TENS & PMS (Model: SM9126) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone Xixiang Road Baoan District Shenzhen, CN 518126 |
| Contact | Xu Jianhua |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-01-19 |
| Decision Date | 2022-02-17 |