The following data is part of a premarket notification filed by Hong Qiangxing (shen Zhen) Electronics Limited with the FDA for Tens & Pms.
| Device ID | K201354 |
| 510k Number | K201354 |
| Device Name: | TENS & PMS |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone Xixiang Road, Baoan Shenzhen, CN 518126 |
| Contact | Linda Liao |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, CN 201613 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2020-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971712720040 | K201354 | 000 |
| 06971712722266 | K201354 | 000 |
| 06971712720019 | K201354 | 000 |
| 06971712720033 | K201354 | 000 |
| 06971712727513 | K201354 | 000 |
| 06971712727537 | K201354 | 000 |
| 06971712727551 | K201354 | 000 |
| 06971712727353 | K201354 | 000 |
| 06971712720026 | K201354 | 000 |
| 06971712722259 | K201354 | 000 |