Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611558

FEI Number

3003255512

Entity Name

HIVOX BIOTEK INC.

City/State/Country

New Taipei City, TW

Establishment Address

5 F., NO. 123, Xingde Road, Sanchong District, New Taipei City 24158, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HIVOX BIOTEK, INC. (Owner Number: 9044329)

Owner / Operator Contact Address

5 F., NO. 123, Xingde Road, Sanchong District, New Taipei City, TW-NOTA 24158, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141921

PMA Number

N/A

All Registered Proprietary Names

Hivox Pure Enrichment PUREPULSE GO WIRELESS TENS THERAPY + HEAT, model: PETNHTPR HIVOX OTC Electrical Stimulator, EM59-2 HIVOX OTC Electrical Stimulator, EM59-1 3-in-1 TENS/EMS device with heat Pain Pad relief, Model: WT-110 Electric Stimulator OTC TENS, Pennypad 904, 907, 909 HIVOX OTC Electrical Stimulator SELF ADHESIVE ELECTRODE GEL PADS HIVOX Reusable Self Adhesive Electrode SP910 SP920 SP620 Abs Muscle Trainer, Model: WE-120 Arm & Leg Muscle Trainer, Model: WE-110

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-11-13
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-01-28
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-05-31
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-05-31
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-03-18
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-03-18
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2012-04-04
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2018-05-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-05-23
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-10-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-10-25
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2015-10-25
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2013-03-13
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2018-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

HIVOX BIOTEK, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611558. Last updated year: 2026. Please use registration number 9611558 when referencing this establishment in official correspondence.