Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015060202

FEI Number

3015060202

Entity Name

DONG GUAN OU KANG ELECTRONICS CO.,LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

3rd floor, Xiqunli building, Shipai road, Yanwo village, Shipai town, Dongguan Guangdong 523000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dong Guan Ou Kang Electronics CO.,LTD (Owner Number: 10058931)

Owner / Operator Contact Address

3rd floor, Xiqunli building, Shipai road, Yanwo village, Shipai town, Dongguan, CN-GD 523000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181234

PMA Number

N/A

All Registered Proprietary Names

Oukang, Self-adhesive electrode, Model: Lead wire type electrode; snap type electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-11-12

Official Correspondent

Nianjun Liu

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

Dong Guan Ou Kang Electronics CO.,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 3015060202. Last updated year: 2026. Please use registration number 3015060202 when referencing this establishment in official correspondence.