The following data is part of a premarket notification filed by Wat Medical Technology Inc. with the FDA for Tens Device-emeterm 2, Model: Yf-zty-e2.
| Device ID | K220503 |
| 510k Number | K220503 |
| Device Name: | TENS Device-EmeTerm 2, Model: YF-ZTY-E2 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WAT Medical Technology Inc. Room703-711, No.2 North Taoyuan Road Ningbo, CN 315600 |
| Contact | Joe Xu |
| Correspondent | Joe Xu WAT Medical Technology Inc. Room703-711, No.2 North Taoyuan Road Ningbo, CN 315600 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971760280111 | K220503 | 000 |