Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010417025

FEI Number

3010417025

Entity Name

HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD

City/State/Country

Hefei Anhui, CN

Establishment Address

Building D17/22, Baiyan Science & Technology Industrial Park, No.168 XiangZhang Road,, Hefei Anhui 230088, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD (Owner Number: 10044091)

Owner / Operator Contact Address

Building D17/22, Baiyan Science & Techno, No.168 XiangZhang Road,, Hefei, CN-AH 230088, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102598

PMA Number

N/A

All Registered Proprietary Names

Wrap Accessory Electrodes Pulsed Electromagnetic Field Wrap HIDOW Wireless TENS/EMS Hi-Dow Pro Touch Wireless 6-12 (HD-19A) Hidow TENS/EMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-08-07
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-09-15
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2021-11-01
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2021-11-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-12-09
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-12-09
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-01-22
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-01-22
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2014-10-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2014-10-08

Official Correspondent

Eric Chen

US Agent Details

Eric Chen Business: Hi-Dow International Incorporated Email: eric@hidow.com Phone: (314) 5692888

Related Public Records

Same Entity

HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD

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
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
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

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3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010417025. Last updated year: 2026. Please use registration number 3010417025 when referencing this establishment in official correspondence.