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Hivox Biotek, Inc.

Taiwan · Taipei

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 13 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States13 registration records, 18 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: HIVOX BIOTEK INC.

FDA 510(k) clearances by year

12002

12003

12010

12012

22014

22015

12017

22019

22021

12022

22023

12024

12026

FDA listed device types

Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Pad, Heating, Powered 1Media, Electroconductive 1Electrode, Cutaneous 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260425	TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)	2026-06-16
US	K242815	POCKET TENS (EP-300)	2024-12-17
US	K232675	Heating Tens, FT-615	2023-10-05
CA	91916	RAPID RELIEF ELECTRONIC PAIN RELIEF PAD	Class II

Hivox Biotek, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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