The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Hivox Otc Electrical Stimulator, Em59-l, Hivox Otc Electrical Stimulator, Em59-2.
|Device Name:||HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2|
|Classification||Stimulator, Nerve, Transcutaneous, Over-the-counter|
|Applicant||Hivox Biotek Inc. SF, No. 123, Xingde Road, Sanchong District, New Taipei City, TW 241|
Hivox Biotek Inc. 5F, No. 123, Xingde Road, Sanchong District, New Taipei City, TW 241
|CFR Regulation Number||882.5890 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|