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Kangfu Medical Equipment Factory: FDA-registered device maker in Wenzhou Zhejiang, China, 2 510(k) clearances

Name: Kangfu Medical Equipment Factory FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kangfu Medical Equipment Factory is registered with the FDA (registration 3015140207) in Wenzhou Zhejiang, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 10, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015140207
Address: No.380 Ningkang East Road, Yueqing, Wenzhou Zhejiang, China, 325600
Owner or operator: Kangfu Medical Equipment Factory (10059139)
Roles: Exporter to the US, Manufacturer
First device listed: December 4, 2018
Registered through: 2026
Brand names listed: COCET, COCET Digital Thermometer, Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter, Hearing Aid, Air-Conduction with Wireless Technology, Prescription, Hearing Aid, Air-Conduction, Over the Counter, Hearing Aid, Air-Conduction, Prescription, KFT-01 KFT-02 KFT-03 KFT-03C KFT-04 KFT-05 KFT-05L KFT-06 KFT-07 KFT-08 KFT-09 KFT-10 KFT-11 KFT-12 KFT-13 KFT-14 KFT-15, KFT-16 KFT-17 KFT-18 KFT-22 KFT-22M KFT-23 KFT- 24 KFT-25 KFT-26 KFT-27 KFT-28

Devices it lists

Device	Product code	Class	Role	Source
Clinical Electronic Thermometer	SDV	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Over The Counter	QUF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	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
December 10, 2021	K201600	Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28	FLL	Substantially Equivalent	Kangfu Medical Equipment Factory	accessdata.fda.gov
November 20, 2018	K182652	COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10	FLL	Substantially Equivalent	Kangfu Medical Equipment Factory	accessdata.fda.gov

Compare with other makers

Updated December 10, 2021. 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.