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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 53 of 91
DeviceModel / ReferenceRegistriesClassStatus
Lumex FR587WDH6725
FDA UDI
Class IActive
Intensa IN587WDH9208
FDA UDI
Class IActive
Intensa IN587WDH6714
FDA UDI
Class IActive
Intensa IN566GHAQ
FDA UDI
Class IActive
Intensa 744B-T4
FDA UDI
Class IActive
Intensa 460-FS-DW-NO
FDA UDI
Class IActive
Intensa 7408-B-TL
FDA UDI
Class IActive
Intensa 620-AL
FDA UDI
Class IActive
Intensa IN587WH1315
FDA UDI
Class IActive
Intensa IN587WH427
FDA UDI
Class IActive
Intensa 7408-CB-NA
FDA UDI
Class IActive
Intensa IN601PPU
FDA UDI
Class IActive
Intensa IN587W9212
FDA UDI
Class IActive
Everest & Jennings 3G010320
FDA UDI
Class IActive
John Bunn JB0112-090
FDA UDI
Class IIActive
Intensa IN566DGHPL
FDA UDI
Class IActive
Everest & Jennings 12022010
FDA UDI
Class IActive
Everest & Jennings EJ787-1
FDA UDI
Class IActive
Grafco 1358-1
FDA UDI
Class IActive
Grafco 1196#1
FDA UDI
Class IActive
Intensa 460-FS-DW-TE
FDA UDI
Class IActive
Lumex 574G432
FDA UDI
Class IActive
Intensa 460-FL-GR
FDA UDI
Class IActive
Intensa 460-FL-WW
FDA UDI
Class IActive
Intensa 620-DA-SH
FDA UDI
Class IActive
Intensa IN566DGH1315
FDA UDI
Class IActive
Lumex FR587WD1304PA
FDA UDI
Class IActive
Intensa 460-DW-T5
FDA UDI
Class IActive
Lumex FR566GH9212PA
FDA UDI
Class IActive
Hausted 4600-AA-SH
FDA UDI
Class IActive
Intensa IN577RGNAPA
FDA UDI
Class IActive
Intensa IN566DG9208
FDA UDI
Class IActive
Lumex FR566DGH6727PA
FDA UDI
Class IActive
Intensa IN577RGHAL
FDA UDI
Class IActive
Grafco 2643
FDA UDI
Class IActive
Lumex FR577RGH1318
FDA UDI
Class IActive
Intensa 744B-PL
FDA UDI
Class IActive
Intensa IN587W1318PA
FDA UDI
Class IActive
Intensa 460-COM
FDA UDI
Class IActive
Intensa IN587WHNOPA
FDA UDI
Class IActive
Lumiscope 100-001TH
FDA UDI
Class IIActive
Intensa 420-DW-T4
FDA UDI
Class IActive
Lumex FR566G1323PA
FDA UDI
Class IActive
Intensa 7408-BU
FDA UDI
Class IActive
Intensa IN577RG409
FDA UDI
Class IActive
Lumex FR587WD427PA
FDA UDI
Class IActive
Intensa 460-FL-TE
FDA UDI
Class IActive
Intensa 460-AA-T6
FDA UDI
Class IActive
Intensa 620-T9
FDA UDI
Class IActive
John Bunn GF61400
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.