The following data is part of a premarket notification filed by Changsha Yuwen Medical Equipment Co.,ltd. with the FDA for Tens And Ems Stimulation (otc).
| Device ID | K212184 |
| 510k Number | K212184 |
| Device Name: | TENS And EMS Stimulation (OTC) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Changsha Yuwen Medical Equipment Co.,Ltd. Room 2404, Kairui Building, No. 245 Laodong West Road, Tianxin District, Changsha, Hunan. Changsha, CN 410004 |
| Contact | Dahui Chen |
| Correspondent | Eva Li Microkn Business Consulting (Shanghai) Co., Ltd Room 1215, Block A, No 3699, Gonghexin Road, Jingan District, Shanghai, China Shanghai, CN 200435 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-13 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010656303 | K212184 | 000 |