The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for A6 Otc Pain Relief Tens.
Device ID | K182753 |
510k Number | K182753 |
Device Name: | A6 OTC Pain Relief TENS |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Sec. 3, Beishen Rd. Shenkeng Dist. New Taipei City, TW 22203 |
Contact | Paul Hung |
Correspondent | Aaron Hage DuVal & Associates 825 Nicollet Mall Suite 1820 Minneapolis, MN 55402 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-28 |
Decision Date | 2018-10-26 |