Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010405397

FEI Number

3010405397

Entity Name

INTELLICARE CO., LTD.

City/State/Country

Hong Kong, HK

Establishment Address

9B, Amtel Building , 148 Des Voeux Rd Central, Hong Kong 999077, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

IntelliCare Co., Ltd. (Owner Number: 10043874)

Owner / Operator Contact Address

9B, Amtel Building, 148 Des Voeux Rd Central, HongKong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211263

PMA Number

N/A

All Registered Proprietary Names

Intrelief PFE EasySTIM NMS-28 EMS Unit SmartTENS Intrelief Combo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-04-01
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2025-12-31
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-04-01
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2013-04-01
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-07-03
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2013-04-01
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2013-04-01
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2013-04-01
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-07-03
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2014-05-29
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-11-23
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-11-23

Official Correspondent

Winnie Lee

US Agent Details

Mateo Carrasco Business: Carrasco Email: mateo@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

IntelliCare Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

Similar Registrations

Registration Number	Establishment Name	Location
3007661914	AB ELECTRONICS	Danbury, CT, US
3037967280	ALGIAMED TECHNOLOGIES USA INC	Lake Mary, FL, US
3041000312	SYSTEC ENGINEERING, LLC	Euless, TX, US
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010405397. Last updated year: 2026. Please use registration number 3010405397 when referencing this establishment in official correspondence.