FDA.reportPublic FDA data

HIVOX BIOTEK INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96115583003255512HIVOX BIOTEK INC.1N2026-01-015 F., NO. 123, Xingde Road Sanchong District New Taipei City TW 24158

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
196391240292275K242815POCKET TENS (EP-300)NUH2024-12-17
196391432205777K232675Heating Tens, FT-615NUH2023-10-05
196391153094702K223308HEATING TENS/EMS, FT-810RNUH2023-05-13
196391687097801K211403HIVOX OTC Electrical Stimulator, FT610-BNUH2021-10-15
196391703543458K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2NUH2021-03-10
196391498813529K192264HIVOX Spopad EMS SP-911, SP-921NGX2019-11-08
196391029439561K171803HIVOX OTC Electrical StimulatorNUH2017-11-29
196391415891462K160323FlowKeepersNGX2017-04-06
196391773799653K143737EM25 - glute toning deviceNGX2015-07-27
196391969955049K141921HIVOX SPOPAD EMSNGX2015-01-16
196391710126696K140650HIVOX ELECTRIC STIMULATOR OTC TENSNUH2014-06-27
196391303969695K131720HIVOX SELF ADHESIVE ELECTRODE GEL PADSGXY2014-07-25
196391987136642K112392HIVOX BIOTEK INC.NUH2012-03-19
196391899838335K092448HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2GZJ2010-03-30
196391155421894K062675GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIESGXY2007-01-04
196391345420648K021952HIVOX DREAMATE DM-800GZJ2003-05-02
196391649583456K020471HIVOX EAR THERMOMETER, TS SERIESFLL2002-05-02
196391414192478

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUH82024-12-17
NGX42019-11-08
GXY22014-07-25
GZJ22010-03-30
FLL12002-05-02

PMN#

GUDID#