Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710580

FEI Number

3003514353

Entity Name

HOME CARE TECHNOLOGY CO., LTD.

City/State/Country

TAINAN CITY, TW

Establishment Address

116, LANE 523, SEC.3, JUNG, JENG RD., JEN TER DISTRICT, TAINAN CITY 71757, TW

Establishment Type(s)

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

Owner / Operator

HOME CARE TECHNOLOGY CO., LTD. (Owner Number: 9044639)

Owner / Operator Contact Address

116, LANE 523, SEC.3, JUNG, JENG RD., JEN TER DISTRICT, TAINAN CITY, TW-TNN 71757, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022917

PMA Number

N/A

All Registered Proprietary Names

HOME CARE HT701 SERIES HOME CARE COLD HOT PACK Home Care HT-326L Electrode Wire and Cable HOME CARE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2004-08-06
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2002-05-17
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2009-08-05
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2014-08-10
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-11-05

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

HOME CARE TECHNOLOGY 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
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
K820884	Nitron Electronics	ELECTRICAL MUSCLE STIMULATOR	1982-04-29
K201958	Therasigma, LLC	ETD Family of Electrotherapy Devices	2020-08-04

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710580. Last updated year: 2026. Please use registration number 9710580 when referencing this establishment in official correspondence.