The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Ev-804 Otc Pain Relief Tens.
Device ID | K172919 |
510k Number | K172919 |
Device Name: | EV-804 OTC Pain Relief TENS |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd. Shenkeng Dist New Taipei City, TW 22203 |
Contact | Paul Hung |
Correspondent | Paul Hung Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd. Shenkeng Dist New Taipei City, TW 22203 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-25 |
Decision Date | 2018-04-19 |