The following data is part of a premarket notification filed by Shenzhen Jian Feng Electronic Technology Co. Ltd. with the FDA for Tens & Ems Device.
| Device ID | K213835 |
| 510k Number | K213835 |
| Device Name: | TENS & EMS Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Jian Feng Electronic Technology Co. Ltd. 902,903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen, CN 518104 |
| Contact | Feng Wen |
| Correspondent | Feng Wen Shenzhen Jian Feng Electronic Technology Co. Ltd. 902,903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen, CN 518104 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-03-03 |