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Merits Health Products., Inc.: FDA-registered device maker in Fort Myers, FL, United States, 16 510(k) clearances

Name: Merits Health Products., Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Merits Health Products., Inc. is registered with the FDA (registration 1058069) in Fort Myers, FL, United States. It lists 9 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 18, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 1058069
FEI number: 1000221992
Address: 4245 Evans Avenue, Fort Myers, FL, United States, 33901
Owner or operator: MERITS HEALTH PRODUCTS., INC. (9008072)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: February 21, 2012
Registered through: 2026
Brand names listed: A903, H103, H103 Patient Lift Hydraulic, P101, P171, P181, P182, P183, P200, P201, P301, P3101, P314, P320, P321, P312, P325 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Repackager or relabeler	accessdata.fda.gov
Components, Wheelchair	KNN	1	Repackager or relabeler	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Repackager or relabeler	accessdata.fda.gov
Lift, Patient, Ac-Powered	FNG	2	Repackager or relabeler	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Repackager or relabeler	accessdata.fda.gov
Powered Stairway Chair Lift	PCD	2	Repackager or relabeler	accessdata.fda.gov
Vehicle, Motorized 3-Wheeled	INI	2	Repackager or relabeler	accessdata.fda.gov
Wheelchair, Powered	ITI	2	Contract manufacturer, Repackager or relabeler	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
March 18, 2022	K220529	Merits P335 Powered Wheelchair	ITI	Substantially Equivalent	Merits Health Products Co., Ltd.	accessdata.fda.gov
July 10, 2019	K182471	Scooter	INI	Substantially Equivalent	Tianjin Kepler Vehicle Industry Co. , Ltd.	accessdata.fda.gov
May 1, 2015	K142162	MERITS TRANSFORMER POWER SCOOTER, S941	INI	Substantially Equivalent	Merits Health Products Co., Ltd.	accessdata.fda.gov
January 9, 2013	K122357	MERITS MODEL P322FWD POWERED WHEELCHAIR	ITI	Substantially Equivalent	Merits Health Products Co., Ltd.	accessdata.fda.gov
December 11, 2001	K013788	TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5	INI	Substantially Equivalent	Merits Health Products Co., Ltd.	accessdata.fda.gov
September 18, 2001	K012802	MP3CF ELECTRIC WHEELCHAIR	ITI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
August 10, 2001	K011513	MP3U, POWER WHEELCHAIR	ITI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
August 6, 2001	K011751	TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3	INI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
August 3, 2001	K011753	TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4	INI	Substantially Equivalent	Merits Health Products., Inc.	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
August 3, 2001	K011687	MP-3C POWER BASE CHAIR, MODEL MP3C	ITI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
May 9, 2001	K010380	MP3HD BIG BOY, POWER WHEELCHAIR	ITI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
December 27, 2000	K003815	TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER	INI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
November 5, 1999	K993032	MODIFICATION TO MP-3 POWER BASE CHAIR	ITI	Substantially Equivalent	Merits Health Products., Inc.	accessdata.fda.gov
March 4, 1996	K952042	TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER	INI	Substantially Equivalent	Merits Health Products Co., Ltd.	accessdata.fda.gov
March 30, 1994	K933662	MERITS WHEELCHAIR	ITI	Substantially Equivalent for Some Indications	Merits Health Products., Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 1, 2021	87673	Class II	Ongoing	Power Wheelchair	Seat baseplate pin has broken in the field.	accessdata.fda.gov
March 2, 2020	85154	Class II	Terminated	Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.	Pinion gear may disengage from track allowing lift to slip or jolt.	accessdata.fda.gov

Compare with other makers

Updated March 18, 2022. 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.