HIVOX SPOPAD EMS

Stimulator, Muscle, Powered, For Muscle Conditioning

HIVOX BIOTEK, INC.

The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Spopad Ems.

Pre-market Notification Details

Device IDK141921
510k NumberK141921
Device Name:HIVOX SPOPAD EMS
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant HIVOX BIOTEK, INC. 5 F., NO. 123, Shingde Road San-chong District New Taipei City,  TW 24158
ContactKe-min Jen
CorrespondentKe-min Jen
HIVOX BIOTEK, INC. 5 F., NO. 123, Shingde Road San-chong District New Taipei City,  TW 24158
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-16
Decision Date2015-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719880810123 K141921 000

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