The following data is part of a premarket notification filed by Shenzhen Yuehua Xinsen Technology Co., Ltd. with the FDA for Tens & Pms Unit.
| Device ID | K220005 |
| 510k Number | K220005 |
| Device Name: | TENS & PMS Unit |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Yuehua Xinsen Technology Co., Ltd. No. 27-201, Zhongwu 3rd Road, Zhongwu Community, Hangcheng Street, Bao’an District Shenzhen, CN 518128 |
| Contact | Evin Li |
| Correspondent | Iris Fung Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, CN |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-04 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16975785860037 | K220005 | 000 |
| 16975785860006 | K220005 | 000 |