The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Everyway Wireless Tens & Ems Unit.
Device ID | K181707 |
510k Number | K181707 |
Device Name: | Everyway Wireless TENS & EMS Unit |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City, TW 22203 |
Contact | Paul Hung |
Correspondent | Paul Hung Everyway Medical Instruments Co., Ltd. 3Fl., No. 5, Lane 155, Section 3, Peishen Rd., Shenkeng District, 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 | 2018-06-28 |
Decision Date | 2018-09-26 |