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Merits Healthcare Industries. (suzhou) Co., Ltd.: FDA-registered device maker in Jiangsu Province, China, 4 510(k) clearances

Name: Merits Healthcare Industries. (suzhou) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Merits Healthcare Industries. (suzhou) Co., Ltd. is registered with the FDA (registration 9618009) in Jiangsu Province, China. It lists 31 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 11, 2001. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 9618009
FEI number: 3003327839
Address: No. 29 Fuzhou Road Taicang City, Jiangsu Province, China, 215411
Owner or operator: MERITS HEALTHCARE INDUSTRIES. (SUZHOU) CO., LTD. (9045042)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: March 19, 2008
Registered through: 2026
Brand names listed: 3999AM84, ARMBOARD, WHEELCHAIR, ARMREST, WHEELCHAIR, B010, B210, B211, B310, B311 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Manufacturer	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Manufacturer	accessdata.fda.gov
Armboard, Wheelchair	IMY	1	Manufacturer	accessdata.fda.gov
Armrest, Wheelchair	IML	1	Manufacturer	accessdata.fda.gov
Attachment, Commode, Wheelchair	INB	1	Manufacturer	accessdata.fda.gov
Bariatric Bed	OSI	2	Manufacturer	accessdata.fda.gov
Bed, Ac-Powered Adjustable Hospital	FNL	2	Manufacturer	accessdata.fda.gov
Bed, Manual	FNJ	1	Manufacturer	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Manufacturer	accessdata.fda.gov
Board, Lap, Wheelchair	IMX	1	Manufacturer	accessdata.fda.gov
Board, Scooter, Prone	KNL	1	Manufacturer	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Manufacturer	accessdata.fda.gov
Chair And Table, Medical	KMN	1	Manufacturer	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Manufacturer	accessdata.fda.gov
Chair, With Casters	INM	1	Manufacturer	accessdata.fda.gov
Climber, Curb, Wheelchair	IMN	1	Manufacturer	accessdata.fda.gov
Components, Wheelchair	KNN	1	Manufacturer	accessdata.fda.gov
Crutch	IPR	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Cuff, Pusher, Wheelchair	INC	1	Manufacturer	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Manufacturer	accessdata.fda.gov
Device, Anti-Tip, Wheelchair	IMR	1	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Handrim, Wheelchair	IMO	1	Manufacturer	accessdata.fda.gov
Hill Holder, Wheelchair	INA	1	Manufacturer	accessdata.fda.gov
Holder, Crutch And Cane, Wheelchair	IMZ	1	Manufacturer	accessdata.fda.gov
Restraint, Wheelchair, Non-Protective	KID	1	Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Support, Head And Trunk, Wheelchair	IMS	1	Manufacturer	accessdata.fda.gov
Vehicle, Motorized 3-Wheeled	INI	2	Manufacturer	accessdata.fda.gov
Wheelchair, Mechanical	IOR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Wheelchair, Powered	ITI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 11, 2001	K013788	TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5	INI	Substantially Equivalent	Merits Health Products Co., Ltd.	accessdata.fda.gov
August 3, 2001	K011707	TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2	INI	Substantially Equivalent	Merits Medical Industries Co., Ltd.	accessdata.fda.gov
March 30, 1994	K933662	MERITS WHEELCHAIR	ITI	Substantially Equivalent for Some Indications	Merits Health Products., Inc.	accessdata.fda.gov
September 30, 1993	K933406	TRAVEL EASE	IOR	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.