Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058069

FEI Number

1000221992

Entity Name

MERITS HEALTH PRODUCTS., INC.

City/State/Country

Fort Myers, FL, US

Establishment Address

4245 EVANS AVENUE, Fort Myers, FL 33901, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MERITS HEALTH PRODUCTS., INC. (Owner Number: 9008072)

Owner / Operator Contact Address

4245 EVANS AVENUE, --, Fort Myers, FL 33901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K933662

PMA Number

N/A

All Registered Proprietary Names

P3101, P314, P320, P321 P312 S235 S141 P710 P301 S245 H103 Patient Lift Hydraulic A903 S131 P101, P171, P181, P182, P183, P200, P201

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-02-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-02-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2012-02-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2012-02-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-02-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-02-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2012-02-21
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-07-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2019-05-29
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2012-02-21
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2023-06-22
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2012-02-21
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2012-02-21
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2012-02-21
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2012-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERITS HEALTH PRODUCTS., INC.

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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

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.
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

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3036988603	SHENZHEN YATTLL INDUSTRY CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058069. Last updated year: 2026. Please use registration number 1058069 when referencing this establishment in official correspondence.