Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680333

FEI Number

1000334118

Entity Name

MERITS HEALTH PRODUCTS CO., LTD.

City/State/Country

TAICHUNG CITY, TW

Establishment Address

NO. 18, JINGKE RD., T.P.M.T. PARK, NANTUN DISTRICT, TAICHUNG CITY 40852, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MERITS HEALTH PRODUCTS CO., LTD. (Owner Number: 9008298)

Owner / Operator Contact Address

NO. 18, JINGKE RD., T.P.M.T. PARK, NANTUN DISTRICT, TAICHUNG CITY, TW-TXG 40852, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011751

PMA Number

N/A

All Registered Proprietary Names

S141 scooter pioneer scooter S746 POV scooter BELT, WHEELCHAIR POV scooter pioneer scooter scooter DEVICE, ANTI-TIP, WHEELCHAIR Merits Transformer Power Scooter, S941 S941L MERITS STAIR LIFT E603/ E604 E605 Quingo Flyte scooter S551 CHAIR, ADJUSTABLE, MECHANICAL CUFF, PUSHER, WHEELCHAIR power chair Gemini BOARD, SCOOTER, PRONE BOARD, LAP, WHEELCHAIR HANDRIM, WHEELCHAIR RESTRAINT, WHEELCHAIR, NON-PROTECTIVE Reversable Power chair Turnabout Power chair Power Chair Universal Power chair SCOOTER ACCESSORY POWER WHEELCHAIR HILL HOLDER, WHEELCHAIR CHAIR, WITH CASTERS POV scooter scooter pioneer scooter COMPONENTS, WHEELCHAIR MANUAL WHEELCHAIR ACCESSORY Merits P335 Powered Wheelchair CANE~PHYSICAL MEDICINE heavy duty power chair Power chair Merits Yoga Power Scooter, S542 POV scooter pioneer scooter scooter

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	2011-04-27
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2011-04-26
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2015-05-06
PCD	Powered Stairway Chair Lift	Physical Medicine	Class 2	890.5150	2019-08-26
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2020-03-17
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2012-09-07
INC	Cuff, Pusher, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2011-04-27
KNL	Board, Scooter, Prone	Physical Medicine	Class 1	890.5370	2012-09-07
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07
IMO	Handrim, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2012-09-07
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2011-04-27
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2006-06-15
INA	Hill Holder, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2012-09-07
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2011-04-27
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2006-06-15
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2006-06-15
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2022-07-19
IPS	Cane	Physical Medicine	Class 1	890.3075	2003-03-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2011-04-27
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2015-06-24
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2011-04-27

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

MERITS HEALTH 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
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 9680333. Last updated year: 2026. Please use registration number 9680333 when referencing this establishment in official correspondence.