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Easymed Instruments Co., Ltd.: FDA-registered device maker in Daliang, Shunde, Foshan Guangdong, China, 9 510(k) clearances

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

Easymed Instruments Co., Ltd. is registered with the FDA (registration 3004049909) in Daliang, Shunde, Foshan Guangdong, China. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 27, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004049909
Address: 3/F-6/F, Block A, No.4 Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan Guangdong, China, 528300
Owner or operator: EASYMED INSTRUMENTS CO., LTD. (9056597)
Roles: Contract manufacturer, Manufacturer
First device listed: January 2, 2008
Registered through: 2026
Brand names listed: AMPCARE ES, AMPCARE ESP Therapy System, EasySTIM NMS-28 EMS Unit, EasyStim TN28_OTC, IF-4 MultiWave, Intrelief Combo, Intrelief DN01, Intrelief DN01 GR and more

Devices it lists

Device	Product code	Class	Role	Source
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Battery-Powered	BXN	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	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
November 27, 2024	K241899	Pelvic Floor Stimulator (Intrelief PFE)	KPI	Substantially Equivalent	Easymed Instruments Co., Ltd.	accessdata.fda.gov
December 30, 2021	K211263	Intrelief	NUH	Substantially Equivalent	Easymed Instruments Co., Ltd.	accessdata.fda.gov
May 13, 2016	K153045	SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator	BXN	Substantially Equivalent	Easy Med Instrument Co., Ltd.	accessdata.fda.gov
May 29, 2015	K143430	SmartTENS	NUH	Substantially Equivalent	Easy Med Instrument Co., Ltd.	accessdata.fda.gov
August 28, 2014	K140168	EASYSTIM TN28_OTC	NUH	Substantially Equivalent	Easymed Instruments Co., Ltd.	accessdata.fda.gov
June 5, 2012	K120054	ULTIMA NEO	GZJ	Substantially Equivalent	Pain Management Technologies	accessdata.fda.gov
July 30, 2008	K073386	JOINT STIM, MODEL 1000	NYN	Substantially Equivalent	Pain Management Technologies	accessdata.fda.gov
December 12, 2005	K050921	EASYSTIM NMS-28	IPF	Substantially Equivalent	Easy Med Instrument Co., Ltd.	accessdata.fda.gov
April 8, 2004	K040253	EASY MED TN-28 C	GZJ	Substantially Equivalent	Easy Med Instrument Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 27, 2024. 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.