HIVOX BIOTEK INC.

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 Biotek Inc..

Pre-market Notification Details

Device IDK112392
510k NumberK112392
Device Name:HIVOX BIOTEK INC.
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
ContactJen Ke-min
CorrespondentJen Ke-min
HIVOX BIOTEK, INC. NO. 58, FU-CHIUN ST. Hsin-chu City,  TW 30067
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-18
Decision Date2012-03-19
Summary:summary

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