Hivox Biotek, Inc. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)510(k)Jun 16, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 16, 2026
POCKET TENS (EP-300)510(k)Dec 17, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 17, 2024
Heating Tens, FT-615510(k)Oct 5, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Oct 5, 2023
HEATING TENS/EMS, FT-810R510(k)May 13, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 13, 2023
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2510(k)Jun 11, 2022Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jun 11, 2022
HIVOX OTC Electrical Stimulator, FT610-B510(k)Oct 15, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 15, 2021
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2510(k)Mar 10, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 10, 2021