The following data is part of a premarket notification filed by Ningbo Medkinetic Medical Device Co., Ltd. with the FDA for Transcutaneous Electrical Applicator (tea).
| Device ID | K212377 |
| 510k Number | K212377 |
| Device Name: | Transcutaneous Electrical Applicator (TEA) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone(South) Ningbo, CN 315806 |
| Contact | Zhang Wei |
| Correspondent | Zhang Wei Shenzhen Reanny Medical Devices Management Consulting Co Ltd Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone(Sou Ningbo, CN 315806 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2022-04-15 |