HIVOX ELECTRIC STIMULATOR OTC TENS

Stimulator, Nerve, Transcutaneous, Over-the-counter

HIVOX BIOTEK, INC.

The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Electric Stimulator Otc Tens.

Pre-market Notification Details

Device IDK140650
510k NumberK140650
Device Name:HIVOX ELECTRIC STIMULATOR OTC TENS
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant HIVOX BIOTEK, INC. 8 F.,NO. 98, SHINDE RD., SANCHONG CITY Taipei Hsien,  TW 24158
ContactKe-min Jen
CorrespondentKe-min Jen
HIVOX BIOTEK, INC. 8 F.,NO. 98, SHINDE RD., SANCHONG CITY Taipei Hsien,  TW 24158
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-13
Decision Date2014-06-27
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.