The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd with the FDA for Li-battery Powered Otc Tens/ems Combination Stimulator.
|Device Name:||Li-Battery Powered OTC TENS/EMS Combination Stimulator|
|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|
Everyway Medical Instruments Co., Ltd 3FL., No.5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City, TW 22203
|CFR Regulation Number||882.5890 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|