Medical Device Manufacturer · TW , Taipei

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

18 submissions · 18 cleared · Since 2002

Recent clearances: TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237), POCKET TENS (EP-300), Heating Tens, FT-615

18

Total

18

Cleared

0

Denied

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

14 devices

1-14 of 14

Cleared Jun 16, 2026

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

Neurology · 126d

Cleared Dec 17, 2024

POCKET TENS (EP-300)

Neurology · 90d

Cleared Oct 05, 2023

Heating Tens, FT-615

Neurology · 34d

Cleared May 13, 2023

HEATING TENS/EMS, FT-810R

Neurology · 197d

Cleared Jun 11, 2022

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2

Neurology · 29d

Cleared Oct 15, 2021

HIVOX OTC Electrical Stimulator, FT610-B

Neurology · 162d

Cleared Mar 10, 2021

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2

Neurology · 93d

Cleared Mar 15, 2019

HIVOX OTC Electrical Stimulator

Neurology · 29d

Cleared Nov 29, 2017

HIVOX OTC Electrical Stimulator

Neurology · 163d

Cleared Jul 25, 2014

HIVOX SELF ADHESIVE ELECTRODE GEL PADS

Neurology · 408d

Cleared Jun 27, 2014

HIVOX ELECTRIC STIMULATOR OTC TENS

Neurology · 106d

Cleared Mar 19, 2012

HIVOX BIOTEK INC.

Neurology · 214d

Cleared Mar 30, 2010

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2

Neurology · 232d

Cleared May 02, 2003

HIVOX DREAMATE DM-800

Neurology · 323d