The following data is part of a premarket notification filed by Wat Medical Technology (ningbo) Co., Ltd with the FDA for Tens Device-headaterm, Eespress.
| Device ID | K172450 |
| 510k Number | K172450 |
| Device Name: | TENS Device-HeadaTerm, EEspress |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | WAT Medical Technology (Ningbo) Co., Ltd Room703-711, No.2 North Taoyuan Road Ningbo, CN 315600 |
| Contact | Rodney Zhang |
| Correspondent | Rodney Zhang WAT Medical Technology (Ningbo) Co., Ltd Room703-711, No.2 North Taoyuan Road Ningbo, CN 315600 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971760280022 | K172450 | 000 |
| 16971760285000 | K172450 | 000 |