Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005619729

FEI Number

3005619729

Entity Name

CHIEN TI ENTERPRISE CO., LTD.

City/State/Country

Taoyuan, TW

Establishment Address

No. 833, Changxiang Rd., Jiudou Village, Xinwu Dist., Taoyuan 327, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CHIEN TI ENTERPRISE CO., LTD. (Owner Number: 9035328)

Owner / Operator Contact Address

NO. 13, Ln. 227, Fuying Rd.,, Xinzhuang Dist.,, New Taipei City, TW-NOTA 242054, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021617

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	1999-08-10
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	1999-08-10
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2007-12-18
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2002-02-22

Official Correspondent

Vivian Lo

US Agent Details

FERRETTI Chang Business: Noventra Prime Inc Email: ferretti@chienti.com.tw Phone: (909) 4386617

Related Public Records

Same Entity

CHIEN TI ENTERPRISE 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
3006247243	SHANGHAI CHIEN TI MOTOR CO., LTD.	Jia Ding Dist. Shanghai, CN

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 3005619729. Last updated year: 2026. Please use registration number 3005619729 when referencing this establishment in official correspondence.