Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183191

FEI Number

2183191

Entity Name

GF Health Products, Inc.

City/State/Country

Fond du Lac, WI, US

Establishment Address

336 Trowbridge Dr, Fond du Lac, WI 54937, 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

Basic American Medical Products® Zenith, Liberty, Alpha 2, Intro, Matrix II, and Matrix beds BED Hausted Chairs; Electric All Purpose and Surgical LUMEX Recliner Basic American Medical Products® Patriot beds TMP Beds

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2021-11-18
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	1997-02-21
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	1981-05-13
FZK	Chair, Surgical, Non-Electrical	General, Plastic Surgery	Class 1	878.4950	2013-08-29
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	1997-02-21
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2013-08-29
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	1997-02-21

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
2428983	GF Health Products, Inc	Atlanta, GA, 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

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3001657382	R82 A/S	GEDVED Midtjylland, DK
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183191. Last updated year: 2026. Please use registration number 2183191 when referencing this establishment in official correspondence.