Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616881

FEI Number

3002847480

Entity Name

HEARTWAY MEDICAL PRODUCTS CO., LTD.

City/State/Country

TAICHUNG CITY, TW

Establishment Address

No. 6, Gongyequ 25th Rd., Baoshan Vil., Nantun Dist.,, TAICHUNG CITY 408017, TW

Establishment Type(s)

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

Owner / Operator

HEARTWAY MEDICAL PRODUCTS CO., LTD. (Owner Number: 9030564)

Owner / Operator Contact Address

No. 6, Gongyequ 25th Rd., Baoshan Vil., Nantun Dist.,, Taichung City, TW-TXG 408017, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070489

PMA Number

N/A

All Registered Proprietary Names

HEARTWAY Heartway Scooter, S34 HEARTWAY Heartway Heartway HEARTWAY Electrically Powered Wheelchair, Model P19 BRIO S19 Scooter Cute Mini S16 Scooter Heartway Heartway Heartway S8 Power Mobility Scooter Heartway Heartway Scooter, S11 HEARTWAY HP6 Heartway Heartway Heartway Heartway Powered Wheelchair, P23 Heartway PF2 Heartway HEARTWAY Power Mobility Scooter, model S15 Heartway Heartway Heartway PF6 Heartway S9 Power Mobility Scooter HEARTWAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2007-11-28
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2012-11-13
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2007-11-28
IMM	Footrest, Wheelchair	Physical Medicine	Class 1	890.3920	1998-01-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2008-03-28
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2015-03-12
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2015-10-18
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2015-10-18
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2008-03-28
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	1998-01-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2009-10-27
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	1998-01-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2012-11-13
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2011-04-07
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2008-03-28
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2008-03-28
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	1998-01-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-11-13
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2009-08-10
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2008-11-09
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2014-11-04
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	1998-01-21
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	1998-01-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2008-03-28
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2009-10-27
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2007-11-28

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

HEARTWAY MEDICAL PRODUCTS 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
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 9616881. Last updated year: 2026. Please use registration number 9616881 when referencing this establishment in official correspondence.