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 |
06973810850070 | K202866 | 000 |
16973810851517 | K202866 | 000 |
16973810850091 | K202866 | 000 |