Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005214422

FEI Number

3005214422

Entity Name

HOMECARE ENTERPRISE CO., LTD.

City/State/Country

Changhua City, TW

Establishment Address

No. 5, Lane 476, Lunmei Road, Changhua City 500, TW

Establishment Type(s)

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

Owner / Operator

HOMECARE ENTERPRISE CO., LTD. (Owner Number: 9074319)

Owner / Operator Contact Address

No. 5, Lane 476, Lunmei Road, Changhua City, TW-CHA 500, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hospital Table and Chair cane HOMECARE Non-Measuring Exerciser Homecare recreational device IV Pole IV Stand Walkers, Rollators, and Accesssories HOMECARE Commode Chair Transfer Aid or Multiple Bed Rails

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2012-09-22
IPS	Cane	Physical Medicine	Class 1	890.3075	2005-06-20
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2008-07-02
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2011-11-16
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2008-05-07
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2005-06-20
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2005-06-20
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2018-07-12
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2008-07-01
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2011-04-13

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

HOMECARE ENTERPRISE 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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1063324	REACT Innovations	Charlotte, NC, US
3043460907	Drive DeVilbiss Healthcare	Perris, CA, US
3008533516	Intensa, Inc.	High Point, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005214422. Last updated year: 2026. Please use registration number 3005214422 when referencing this establishment in official correspondence.