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Cathay Manufacturing Corp.: FDA-registered device maker in Shanghai, China, 5 510(k) clearances

Name: Cathay Manufacturing Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cathay Manufacturing Corp. is registered with the FDA (registration 3009555600) in Shanghai, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 21, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009555600
Address: No. 328, Xishe Road, Maogang Town Songjiang Area, Shanghai, China, 201607
Owner or operator: Cathay Manufacturing Corp. (9046141)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed: February 27, 2008
Registered through: 2026
Brand names listed: Cathay, Disposable Neutral Electrode, Electrode Cable, FlexTone replacement electrodes, TENS Cable

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 21, 2022	K203293	Abbott Medical Grounding Pad, model RF-DGP-IS	GXD	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
July 19, 2018	K170369	Disposable Electrosurgical Pencils	GEI	Substantially Equivalent	Cathay Manfacturing Corp.	accessdata.fda.gov
October 19, 2016	K160081	TENS Electrodes	GXY	Substantially Equivalent	Cathay Manufacturing Corp.	accessdata.fda.gov
August 22, 2013	K130027	DISPOSABLE NEUTRAL ELECTRODE GP202	GEI	Substantially Equivalent	Cathay Manufacturing Corp.	accessdata.fda.gov
July 12, 2002	K020735	SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES	GXY	Substantially Equivalent	Cathay International, Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.