Medical Device Manufacturer · TW , Taipei

Hivox Biotek, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2002
17
Total
17
Cleared
0
Denied

Hivox Biotek, Inc. has 17 FDA 510(k) cleared neurology devices. Based in Taipei, TW.

Latest FDA clearance: Dec 2024. Active since 2002.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Hivox Biotek, Inc.
17 devices
1-17 of 17
Cleared Dec 17, 2024
POCKET TENS (EP-300)
K242815 · NUH
Neurology · 90d
Cleared Oct 05, 2023
Heating Tens, FT-615
K232675 · NUH
Neurology · 34d
Cleared May 13, 2023
HEATING TENS/EMS, FT-810R
K223308 · NUH
Neurology · 197d
Cleared Jun 11, 2022
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384 · NUH
Neurology · 29d
Cleared Oct 15, 2021
HIVOX OTC Electrical Stimulator, FT610-B
K211403 · NUH
Neurology · 162d
Cleared Mar 10, 2021
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
K203574 · NUH
Neurology · 93d
Cleared Nov 08, 2019
HIVOX Spopad EMS SP-911, SP-921
K192264 · NGX
Physical Medicine · 79d
Cleared Mar 15, 2019
HIVOX OTC Electrical Stimulator
K190347 · NUH
Neurology · 29d
Cleared Nov 29, 2017
HIVOX OTC Electrical Stimulator
K171803 · NUH
Neurology · 163d
Cleared Jul 27, 2015
EM25 - glute toning device
K143737 · NGX
Physical Medicine · 209d
Cleared Jan 16, 2015
HIVOX SPOPAD EMS
K141921 · NGX
Physical Medicine · 184d
Cleared Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · GXY
Neurology · 408d
Cleared Jun 27, 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · NUH
Neurology · 106d
Cleared Mar 19, 2012
HIVOX BIOTEK INC.
K112392 · NUH
Neurology · 214d
Cleared Mar 30, 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K092448 · GZJ
Neurology · 232d
Cleared May 02, 2003
HIVOX DREAMATE DM-800
K021952 · GZJ
Neurology · 323d
Cleared May 02, 2002
HIVOX EAR THERMOMETER, TS SERIES
K020471 · FLL
General Hospital · 79d
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