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GF Health Products, Inc

United States·US-MF-000002167

Last updated September 17, 2026

What GF Health Products, Inc makes

GF Health Products, Inc. manufactures medical furniture and mobility aids, including reclining chairs, examination and treatment tables (both manual and line-powered), general examination chairs, basic electric hospital beds, operating room stools, and non-bariatric push-rim wheelchairs. The company also produces mechanical external stethoscopes and related accessories.

The portfolio includes devices classified as Class I, Class II, and non-classified (N), all listed in the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does GF Health Products, Inc. manufacture?

GF Health Products, Inc. specializes in medical furniture and mobility aids. Their portfolio includes reclining chairs, examination and treatment tables (both manual and line-powered), general examination chairs, basic electric hospital beds, operating room stools, non-bariatric push-rim wheelchairs, and mechanical external stethoscopes. These devices are designed for clinical, hospital, and patient care environments.

Where is GF Health Products, Inc. based?

GF Health Products, Inc. is headquartered in the United States. The company’s location ensures it operates within U.S. regulatory frameworks, including those governing medical device classification and compliance.

Which regulatory registries or databases list GF Health Products, Inc.’s devices?

GF Health Products, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry ensures traceability and transparency in the medical device supply chain, allowing for easier tracking and compliance verification.

How are GF Health Products, Inc.’s devices classified under U.S. regulations?

GF Health Products, Inc.’s devices fall into three classification categories: Class I (generally low-risk devices), Class II (devices with moderate risk requiring special controls), and non-classified (N) devices. Classification determines regulatory requirements, with Class I devices typically requiring less stringent oversight than Class II.

What distinguishes the mechanical external stethoscopes produced by GF Health Products, Inc.?

GF Health Products, Inc. manufactures mechanical external stethoscopes, which are designed for auscultation (listening to internal body sounds). Unlike electronic stethoscopes, these devices rely on manual amplification and are classified as medical devices intended for clinical use in examining patients. Their simplicity and durability make them suitable for various healthcare settings.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
One Graham Field Way, Atlanta, United States
LinkedIn
—
Facebook
—
Phone
+17703684700
PRRC Contact
Amy Piccini
EUDAMED SRN
US-MF-000002167
FDA FEI Number
2427360
DUNS Number
—

Catalogue (4538)

Page 44 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa IN566DGHAL
FDA UDI
Class IActive
Intensa IN597P8615
FDA UDI
Class IActive
Hausted ESCEYEST
FDA UDI
Class IUnknown
Intensa 460-FS-AA-T9
FDA UDI
Class IActive
Lumex FR587WH1318
FDA UDI
Class IActive
Intensa 620-DA-DO
FDA UDI
Class IActive
Lumex FR597P9201
FDA UDI
Class IActive
Basic American Medical Products ZZ7AF35
FDA UDI
Class IIActive
Everest & Jennings 8930186
FDA UDI
Class IActive
Hausted 4600-FS-DW-WW
FDA UDI
Class IActive
Intensa IN577RG8584PA
FDA UDI
Class IActive
Intensa IN577RGH8604PA
FDA UDI
Class IActive
Lumiscope SW-1000
FDA UDI
Class IIActive
Intensa IN587WH1311PA
FDA UDI
Class IActive
Gendron PL700
FDA UDI
Class IIActive
Lumex LF1031FP
FDA UDI
Class IActive
Intensa 460-AA-PS-T2
FDA UDI
Class IActive
Basic American Medical Products MP7174
FDA UDI
Class IIActive
Intensa IN587WDH6727PA
FDA UDI
Class IActive
SIMMONS Clinical Care 770000S
FDA UDI
Class IIActive
Intensa 460-FS-AA-PS-AL
FDA UDI
Class IActive
Lumex FR566DGH6705
FDA UDI
Class IActive
Hausted 4600-PS-AQ
FDA UDI
Class IActive
Hausted 4600-FS-TL
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-WH
FDA UDI
Class IActive
Intensa IN577RGHPLPA
FDA UDI
Class IActive
Lumex GF1840C-2
FDA UDI
Class IActive
Intensa IN587WOG
FDA UDI
Class IActive
Intensa 748-AL
FDA UDI
Class IActive
Intensa 460-FS-AA-NO
FDA UDI
Class IActive
Intensa IN577RGDO
FDA UDI
Class IActive
Hausted 4600-DW-WW
FDA UDI
Class IActive
Intensa IN566DG6717PA
FDA UDI
Class IActive
Intensa 420-DW-T10
FDA UDI
Class IActive
Lumex DM81
FDA UDI
Class IActive
Grafco 1196F#3
FDA UDI
Class IActive
Intensa 460-DW-OG
FDA UDI
Class IActive
Intensa 744B-T3
FDA UDI
Class IActive
Everest & Jennings 3G010350
FDA UDI
Class IActive
Intensa 748-WW
FDA UDI
Class IActive
Intensa 460-AA-DW-BT
FDA UDI
Class IActive
Intensa IN587WH8516
FDA UDI
Class IActive
Lumex 822219
FDA UDI
Class IActive
Intensa IN566GH8567
FDA UDI
Class IActive
Lumex FR577RGH9201PA
FDA UDI
Class IActive
Everest & Jennings 90763440
FDA UDI
Class IUnknown
Lumex FR565WG8818
FDA UDI
Class IActive
Intensa IN577RGMO
FDA UDI
Class IActive
Intensa 748CB-ST
FDA UDI
Class IActive
Hausted 4600-FL-AL
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

GF Health Products, Inc. has three recall records initiated between September 14, 2009, and March 24, 2021, all of which are marked as terminated. The reasons include incorrect front casters on the 6810A Lumex Drop Arm Versamode, a material change in trach tubes from stainless steel to German silver/nickel without matching specifications, and a voluntary field correction involving the OKIN America 'DUOMAT 3' Head/Foot motor used in certain Lumex Patriot Full Electric Bed models.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Mar 24, 2021Z-1353-2021—terminated

The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.

Sep 30, 2016Z-0732-2017—terminated

GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.

Sep 14, 2009Z-0139-2010—terminated

Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.