Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022865

FEI Number

3915

Entity Name

SHIH KUO ENTERPRISE CO., LTD.

City/State/Country

Tainan, TW

Establishment Address

No. 71, Lane 54, Sec. 2, An-Ho Rd., Tainan 709, TW

Establishment Type(s)

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

Owner / Operator

SHIH KUO Enterprise Co., Ltd. (Owner Number: 10050769)

Owner / Operator Contact Address

No. 71, Lane 54, Sec. 2, An-Ho Rd., Tainan, TW-TNN 709, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Overbed Table Med-Gear Tube Rail/Commode Rail Mechanical Walker Med-Gear Bath Chairs/Shower Chairs/cushions/Commode Seat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2020-10-15
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-12-24
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-10-26
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-12-24

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

SHIH KUO 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022865. Last updated year: 2026. Please use registration number 8022865 when referencing this establishment in official correspondence.