The following data is part of a premarket notification filed by Shenzhen Jianfeng Electronic Technology Co., Ltd. with the FDA for Tens & Ems Device.
| Device ID | K202866 |
| 510k Number | K202866 |
| Device Name: | TENS & EMS Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SHenzhen Jianfeng Electronic Technology Co., Ltd. #902,903 Jialingyu Industry Building, Dapu Road, Houting, Shajing Town Baoan District, Shenzhen City, CN 518104 |
| Contact | Feng Wen |
| Correspondent | Iris Lin Intertek Testing Services Shenzhen Ltd. Guangzhou. Block E, No.7-2 Guangdong Software Science Park, Caipin Road Guangzhou Science City, Getdd, CN 510700 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973810850056 | K202866 | 000 |
| 16973810850107 | K202866 | 000 |
| 16973810850114 | K202866 | 000 |
| 16973810850121 | K202866 | 000 |
| 16973810850138 | K202866 | 000 |
| 16973810850145 | K202866 | 000 |
| 16973810850169 | K202866 | 000 |
| 16973810850176 | K202866 | 000 |
| 16973810850183 | K202866 | 000 |
| 16973810850190 | K202866 | 000 |
| 16973810850206 | K202866 | 000 |
| 16973810850213 | K202866 | 000 |
| 16973810850220 | K202866 | 000 |
| 16973810850237 | K202866 | 000 |
| 16973810850244 | K202866 | 000 |
| 16973810850091 | K202866 | 000 |
| 16973810851517 | K202866 | 000 |
| 06973810850070 | K202866 | 000 |
| 16973810850152 | K202866 | 000 |