Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616873

FEI Number

3003190528

Entity Name

WU'S TECH CO., LTD.

City/State/Country

Hsin-Chu City Hsinchu, TW

Establishment Address

No. 225, Yuan Peir St., Hsin-Chu City Hsinchu 30093, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

WU'S TECH CO., LTD. (Owner Number: 9041713)

Owner / Operator Contact Address

No. 225, Yuan Peir St., Hsin-Chu City, TW-HSQ 30093, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040968

PMA Number

N/A

All Registered Proprietary Names

EURO-TAIWANAISE WU'S WU'S Powered Wheelchair, Mambo 30 EURO-TAIWANAISE WU'S Mambo 2 WU'S Scooter EURO-TAIWANAISE WU'S WU'S EURO-TAIWANAISE Power Scooter EURO-TAIWANAISE WU'S WT-T4DK2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2007-12-02
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2022-05-31
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2007-12-02
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2007-12-02
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2009-08-12
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2005-04-12
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2015-04-30
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2005-04-12
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2007-12-02

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

WU'S TECH CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007963811	WU'S TECH (VIETNAM) Co., Ltd.	Ho Chi Minh City Binh Duong, VN
3004142507	SOCIETE COMMERCIALE EURO-TAIWANAISE	TAIPEI, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue
Z-0037-2007	Medline Industries Inc	2	Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616873. Last updated year: 2026. Please use registration number 9616873 when referencing this establishment in official correspondence.