HIVOX Spopad EMS SP-911, SP-921

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 Sp-911, Sp-921.

Pre-market Notification Details

Device IDK192264
501k NumberK192264
Device Name:HIVOX Spopad EMS SP-911, SP-921
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Hivox Biotek Inc. 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City,  TW 24158
ContactMarx Lee
CorrespondentMarx Lee
Hivox Biotek Inc. 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City,  TW 24158
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyPhysical Medicine
501k Review PanelPhysical Medicine
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-21
Decision Date2019-11-08

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.