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Sign in to claim this brandGF 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
- Website
- www.grahamfield.com
- —
- —
- [email protected]
- Phone
- +17703684700
- PRRC Contact
- Amy Piccini
- EUDAMED SRN
- US-MF-000002167
- FDA FEI Number
- 2427360
- DUNS Number
- —
Catalogue (4538)
Page 40 of 91| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Intensa | 460-FS-PS-NO | FDA UDI | Class I | Active |
| M368460flna1 | 460-FL-NA | FDA UDI | Class I | Active |
| Intensa | 7408-CB-DO | FDA UDI | Class I | Active |
| Intensa | 460-AA-PS-T8 | FDA UDI | Class I | Active |
| LabTron | 202BK | FDA UDI | Class II | Active |
| Intensa | IN566DGOGPA | FDA UDI | Class I | Active |
| Grafco | 3909-1 | FDA UDI | Class I | Active |
| Lumex | FR565WG8628 | FDA UDI | Class I | Active |
| Intensa | 460-FL-PL | FDA UDI | Class I | Active |
| Labtron | 602TL | FDA UDI | Class I | Active |
| Intensa | IN577RGTE | FDA UDI | Class I | Active |
| Intensa | 460-DW-T8 | FDA UDI | Class I | Active |
| SIMMONS Clinical Care | 765000SP | FDA UDI | Class II | Active |
| Intensa | 460-AA-DW-AQ | FDA UDI | Class I | Active |
| Transfer Master | MLB-TOP-QUEEN | FDA UDI | Class II | Active |
| Everest & Jennings | 90835203J | FDA UDI | Class I | Active |
| Lumex | LCM4280B | FDA UDI | Class II | Active |
| Intensa | IN566DG1311PA | FDA UDI | Class I | Active |
| Hausted | 4600-PS-VI | FDA UDI | Class I | Active |
| Intensa | IN577RGH8604 | FDA UDI | Class I | Active |
| Intensa | IN577RGPM | FDA UDI | Class I | Active |
| Lumex | FR601UH1323 | FDA UDI | Class I | Active |
| Everest & Jennings | 3G010520 | FDA UDI | Class I | Active |
| Intensa | 620-T7 | FDA UDI | Class I | Active |
| Everest & Jennings | 90763060A | FDA UDI | Class I | Active |
| Lumex | FR566DGH401 | FDA UDI | Class I | Active |
| Intensa | 460-PS-NO | FDA UDI | Class I | Active |
| Intensa | IN597G8602 | FDA UDI | Class I | Active |
| Intensa | 420-BL | FDA UDI | Class I | Active |
| Hausted | 4600-FS-DW-WH | FDA UDI | Class I | Active |
| Hausted | 4600-DB | FDA UDI | Class I | Active |
| Intensa | 610-T10 | FDA UDI | Class I | Active |
| Intensa | IN587WDHNAPA | FDA UDI | Class I | Active |
| Everest & Jennings | 24040110 | FDA UDI | Class I | Active |
| Hausted | 4600-AA-DW-PM | FDA UDI | Class I | Active |
| Lumex | FR566G8604PA | FDA UDI | Class I | Active |
| Intensa | 460-BU | FDA UDI | Class I | Active |
| Transfer Master | B310-5-F | FDA UDI | Class II | Active |
| Intensa | IN566GTEPA | FDA UDI | Class I | Active |
| Lumex | FR601PH6725 | FDA UDI | Class I | Active |
| Intensa | IN597G6727 | FDA UDI | Class I | Active |
| Labtron | LAB-7300 | FDA UDI | Class I | Active |
| Intensa | IN577RGWW | FDA UDI | Class I | Active |
| Intensa | 420-OG | FDA UDI | Class I | Active |
| Labtron | 513P | FDA UDI | Class I | Active |
| Intensa | 748-VI | FDA UDI | Class I | Active |
| Intensa | IN577RGHPU | FDA UDI | Class I | Active |
| Labtron | 602N-BL | FDA UDI | Class I | Active |
| Lumex | FR588W851 | FDA UDI | Class I | Active |
| Intensa | IN597G9210 | FDA UDI | Class I | Active |
Related Companies
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 24, 2021 | Z-1353-2021 | — | terminated | The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. |
| Sep 30, 2016 | Z-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, 2009 | Z-0139-2010 | — | terminated | Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications. |