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Top-rank Health Care Co.,Ltd.: FDA-registered device maker in Shaoxing Zhejiang, China, 6 510(k) clearances

Name: Top-rank Health Care Co.,Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Top-rank Health Care Co.,Ltd. is registered with the FDA (registration 3006626283) in Shaoxing Zhejiang, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 16, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3006626283
Address: Mashan Village, Dongguan Street Shangyu District, Shaoxing Zhejiang, China, 312352
Owner or operator: Top-Rank Health Care Co.,Ltd (9098583)
Roles: Contract manufacturer, Manufacturer
First device listed: May 30, 2007
Registered through: 2026
Brand names listed: AF100125CP, AF5050CP, Adhesive Electrode, CM13088, CM32D, CM4040, CM4080, CM4545 and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Device, Iontophoresis, Other Uses	EGJ	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Electrosurgical Patient Return Electrode	ODR	2	Manufacturer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Contract manufacturer, 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
October 16, 2023	K232020	Iontophoresis Electrodes	EGJ	Substantially Equivalent	Top-Rank Health Care Co., Ltd.	accessdata.fda.gov
December 13, 2022	K222770	Conductive Gel	GYB	Substantially Equivalent	Top-Rank Health Care Co., Ltd.	accessdata.fda.gov
December 15, 2021	K210223	Transcutaneous Electrical Nerve Stimulator	NUH	Substantially Equivalent	Top-Rank Health Care Co., Ltd.	accessdata.fda.gov
August 19, 2016	K160366	Electrosurgical disposable grounding pads	ODR	Substantially Equivalent	Top-Rank Health Care Co., Ltd.	accessdata.fda.gov
November 22, 2013	K132588	ADHESIVE ELECTRODES	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
May 7, 2007	K070612	TOP-RANK ADHESIVE ELECTRODE	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 16, 2023. 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.