Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9618009

FEI Number

3003327839

Entity Name

MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD.

City/State/Country

JIANGSU PROVINCE, CN

Establishment Address

NO. 29 FUZHOU ROAD, TAICANG CITY, JIANGSU PROVINCE 215411, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD. (Owner Number: 9045042)

Owner / Operator Contact Address

NO. 29 FUZHOU ROAD, TAICANG CITY, JIANGSU PROVINCE, CN-JS 215411, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MANUAL WHEELCHAIR COMPONENTS BELT, WHEELCHAIR PEDAL EXERCISER manual wheel chair accessories BOARD, SCOOTER, PRONE STAND, INFUSION HOLDER, CRUTCH AND CANE, WHEELCHAIR RESTRAINT, WHEELCHAIR, NON-PROTECTIVE C313 D101 C315 C401 C316 C321 C314 C317 C311 C312 3999AM84 CHAIR, ADJUSTABLE, MECHANICAL N473 N421 N472 N700 N211 L223 N480 L247 N451 L405 N2469 N424 L248 L222 CLIMBER, CURB, WHEELCHAIR CUFF, PUSHER, WHEELCHAIR FOREARM CRUTCH CRUTCH UNDERARM CRUTCH OVER BED TABLE P326A P326E P326D CUSHION MERITS MODEL P322FWD POWERED WHEELCHAIR P322A P322B P322 DEVICE, ANTI-TIP, WHEELCHAIR ARMBOARD, WHEELCHAIR ARMREST, WHEELCHAIR BOARD, LAP, WHEELCHAIR SUPPORT, HEAD AND TRUNK, WHEELCHAIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2011-06-01
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2011-06-01
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2010-10-15
KNL	Board, Scooter, Prone	Physical Medicine	Class 1	890.5370	2012-09-07
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2011-08-10
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2012-09-07
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2011-06-01
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2016-03-22
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2012-09-07
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2008-03-19
IMN	Climber, Curb, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
INC	Cuff, Pusher, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07
IPR	Crutch	Physical Medicine	Class 1	890.3150	2011-06-07
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2011-06-01
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-09-28
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2011-12-16
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2023-02-03
IMR	Device, Anti-Tip, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
IMY	Armboard, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2012-09-07
IMX	Board, Lap, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2012-09-07

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 HEALTHCARE INDUSTRIES. (SUZHOU) 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-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.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini 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 9618009. Last updated year: 2026. Please use registration number 9618009 when referencing this establishment in official correspondence.