Data / Medical devices / Hong Kong / Intellicare Co., Ltd.

Intellicare Co., Ltd.: FDA-registered device maker in Hong Kong, Hong Kong, 9 510(k) clearances

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

Intellicare Co., Ltd. is registered with the FDA (registration 3010405397) in Hong Kong, Hong Kong. It lists 7 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: 3010405397
Address: 9B, Amtel Building, 148 Des Voeux Rd Central, Hong Kong, Hong Kong, 999077
Owner or operator: IntelliCare Co., Ltd. (10043874)
Roles: Exporter to the US
First device listed: April 1, 2013
Registered through: 2026
Brand names listed: EasySTIM NMS-28 EMS Unit, Intrelief Combo, Intrelief PFE, SmartTENS

Devices it lists

Device	Product code	Class	Role	Source
Interferential Current Therapy	LIH	2	Exporter to the US	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Exporter to the US	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Exporter to the US	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Exporter to the US	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Exporter to the US	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 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
October 31, 2013	K131222	AMPCARE ESP THERAPY SYSTEM	IPF	Substantially Equivalent	Ampcare, LLC	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.