Medical Device Manufacturer · TW , Taipei

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

18 submissions · 18 cleared · Since 2002

Recent clearances: POCKET TENS (EP-300), Heating Tens, FT-615, HEATING TENS/EMS, FT-810R

Total

Cleared

Denied

Hivox Biotek, Inc. has 18 FDA 510(k) cleared neurology devices. Based in Taipei, TW.

Latest FDA clearance: Jun 2026. 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.

Hivox Biotek, Inc. is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Hivox Biotek, Inc.

18 devices

1-12 of 18

Cleared Jun 16, 2026

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

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

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

FDA 510(k) Regulatory Record - Hivox Biotek, Inc.

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