Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009555600

FEI Number

3009555600

Entity Name

Cathay Manufacturing Corp.

City/State/Country

Shanghai, CN

Establishment Address

No. 328, Xishe Road, Maogang Town, Songjiang Area, Shanghai 201607, CN

Establishment Type(s)

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

Owner / Operator

Cathay Manufacturing Corp. (Owner Number: 9046141)

Owner / Operator Contact Address

No. 328, Xishe Road, Maogang Town, Songjiang Area, Shanghai, CN-NOTA 201607, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130027

PMA Number

N/A

All Registered Proprietary Names

Cathay FlexTone replacement electrodes Electrode Cable TENS Cable Cathay Cathay Cathay Disposable Neutral Electrode Cathay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-02-27
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2013-11-07
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-08-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-09-21
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-09-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-10-28

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

Cathay Manufacturing Corp.

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3015614098	CGX, LLC	San Diego, CA, US
3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
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 3009555600. Last updated year: 2026. Please use registration number 3009555600 when referencing this establishment in official correspondence.