Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2428983

FEI Number

2427360

Entity Name

GF Health Products, Inc

City/State/Country

Atlanta, GA, US

Establishment Address

1 GRAHAM FIELD WAY, Atlanta, GA 30340, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GF Health Products, Inc. (Owner Number: 2428983)

Owner / Operator Contact Address

1 Graham Field Way, Atlanta, GA 30340, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Everest & Jennings, Gendron Maxi Lift Hausted Chairs; Electric All Purpose and Surgical LUMEX Recliner Intensa Clinical Recliners Lumex Clinical Recliners Gendron Shower Commode Gendron Reclining Chair 3789 Bite Block 740 Series HSS500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2009-05-01
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2020-09-17
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2000-10-17
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2013-08-29
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	1996-07-18
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2001-01-26
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	1997-02-21
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1996-07-19
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	1996-07-18
JXL	Block, Bite	Neurology	Class 2	882.5070	2019-06-18
PHS	Oral Airway Assist	Anesthesiology	Class 1	868.5110	2022-01-18
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	1996-07-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GF Health Products, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1218367	GF Health Products, Inc.	Warwick, RI, US
3008533516	Intensa, Inc.	High Point, NC, US
2183191	GF Health Products, Inc.	Fond du Lac, WI, US

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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2428983. Last updated year: 2026. Please use registration number 2428983 when referencing this establishment in official correspondence.