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Famidoc Technology Co., Ltd: FDA-registered device maker in Dong Guan Guangdong, China, 7 510(k) clearances

Name: Famidoc Technology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Famidoc Technology Co., Ltd is registered with the FDA (registration 3005621440) in Dong Guan Guangdong, China. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 10, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005621440
Address: Building 6 Zhongtangtian'An Cyber Park, No. 89, Jinyuan Road, Zhongtang Town, Dong Guan Guangdong, China, 523220
Owner or operator: FAMIDOC TECHNOLOGY CO., LTD. (9078379)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 4, 2013
Registered through: 2026
Brand names listed: Abdominal Fitness Belt, Model FDES107(ED407);, Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A10,FDBP-A10B,FDBP-A10BL,FDBP-A10BT,FDBP-A10BLT), Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A1B,FDBP-A2B,FDBP-A3B,FDBP-A4B,FDBP-A5B,FDBP-A6B), Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A7,FDBP-A7B,FDBP-A7BL,FDBP-A7BT,FDBP-A7BLT), Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A8,FDBP-A8B,FDBP-A8BL,FDBP-A8BT,FDBP-A8BLT), Automatic Wireless Smart Blood Pressure Monitor(Model:FDBP-A9,FDBP-A9B,FDBP-A9BL,FDBP-A9BT,FDBP-A9BLT), Basal Body Thermometer((Model:BBT-127), Braun ThermoScan 3 High Speed Compact Ear Thermometer(Model No.:IRT3030,IRT3030AP,IRT3030US,IRT3030EE,IRT3030WE; and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Repackager or relabeler	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	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
April 10, 2023	K222887	Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor	DXN	Substantially Equivalent	Famidoc Technology Company Limited	accessdata.fda.gov
December 13, 2021	K212918	Heat StimPlus	NUH	Substantially Equivalent	Famidoc Technology Co., Ltd.	accessdata.fda.gov
November 27, 2019	K191673	Upper Arm Blood Pressure Monitor	DXN	Substantially Equivalent	Famidoc Technology Company Limited	accessdata.fda.gov
November 28, 2016	K160530	Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff	DXQ	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov
August 11, 2016	K160138	Adhesive Electrodes	GXY	Substantially Equivalent	Gmdasz Manufacturing Co., Ltd.	accessdata.fda.gov
February 7, 2014	K130723	FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL	NGX	Substantially Equivalent	Famidoc Technology Co., Ltd.	accessdata.fda.gov
December 21, 2012	K113010	FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR	IPF	Substantially Equivalent	Famidoc Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 10, 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.