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Sign in to claim this brandF.F.F. Enterprises, Inc.
US
Last updated May 23, 2026
What F.F.F. Enterprises, Inc. makes
F.F.F. Enterprises, Inc. manufactures the FREE-LANCE, a medical device designed for [specific clinical use not provided in data]. The product falls under the category of [unspecified category, as no further details are given].
The FREE-LANCE is classified as Class II under FDA regulations and requires 510(k) clearance for market authorisation. 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 F.F.F. Enterprises, Inc. manufacture?
F.F.F. Enterprises, Inc. manufactures the FREE-LANCE, a medical device designed for a specific clinical application. While the exact use case is not detailed in the provided data, the device is classified under the FDA’s Class II category, indicating it poses moderate risk and requires regulatory oversight to ensure safety and effectiveness.
Where is F.F.F. Enterprises, Inc. based?
F.F.F. Enterprises, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).
How are the devices manufactured by F.F.F. Enterprises, Inc. classified under FDA regulations?
The FREE-LANCE device produced by F.F.F. Enterprises, Inc. is classified as a Class II medical device by the FDA. This classification means it is subject to special controls beyond general controls to mitigate moderate risks associated with its use, such as performance standards or post-market surveillance requirements.
Which regulatory registries or databases list the devices made by F.F.F. Enterprises, Inc.?
The FREE-LANCE device from F.F.F. Enterprises, Inc. is listed in the FDA’s 510(k) clearance registry. This registry documents devices that have undergone premarket notification review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA regulations before market authorisation.
Why does the FREE-LANCE device require 510(k) clearance?
The FREE-LANCE device requires 510(k) clearance because it is classified as a Class II device under FDA regulations. This classification necessitates a premarket submission to demonstrate that the device is at least as safe and effective as a legally marketed predicate device, ensuring it meets applicable performance standards and regulatory requirements before being authorised for sale.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (397)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Forest | 9078P-INT | FDA UDI | Class I | Active |
| Forest | MT610BS-G | FDA UDI | Class I | Active |
| Forest | 2003INT-G | FDA UDI | Class I | Active |
| Forest | 2184BC | FDA UDI | Class I | Active |
| Forest | MT600BS | FDA UDI | Class I | Active |
| Forest | 1576INT-G | FDA UDI | Class I | Active |
| Forest | 1300TPM-C | FDA UDI | Class I | Active |
| Forest | 9074W-G | FDA UDI | Class I | Active |
| Forest | 9078 | FDA UDI | Class I | Active |
| Forest | 4485SE-G | FDA UDI | Class I | Active |
| Forest | 3486BC-C | FDA UDI | Class I | Active |
| Forest | 7020PRO-UC-G | FDA UDI | Class I | Active |
| Forest | 7010UC | FDA UDI | Class I | Active |
| Forest | 5355C | FDA UDI | Class I | Active |
| Forest | 9073INT | FDA UDI | Class I | Active |
| Forest | 9079C-T | FDA UDI | Class I | Active |
| Forest | 7000INT-DURR | FDA UDI | Class I | Active |
| Forest | 9073C | FDA UDI | Class I | Active |
| Forest | 9078P-INT-G | FDA UDI | Class I | Active |
| Forest | 3800PT-G | FDA UDI | Class I | Active |
| Forest | 1592G | FDA UDI | Class I | Active |
| Forest | 2184BS-MCC | FDA UDI | Class I | Active |
| Forest | 7000INT-DURR-G | FDA UDI | Class I | Active |
| Forest | 2186BC-C | FDA UDI | Class I | Active |
| Forest | 7020PRO-WM-HM | FDA UDI | Class I | Active |
| Forest | 9073P-G | FDA UDI | Class I | Active |
| Forest | 1096G | FDA UDI | Class I | Active |
| Forest | 9074W-T | FDA UDI | Class I | Active |
| Forest | 3386WM-G | FDA UDI | Class I | Active |
| Forest | 9073P-INT-C | FDA UDI | Class I | Active |
| Forest | 7021PRO-BC-G | FDA UDI | Class I | Active |
| Forest | 9079W-G | FDA UDI | Class I | Active |
| Forest | 3486BC | FDA UDI | Class I | Active |
| Forest | 4485FE-G | FDA UDI | Class I | Active |
| Forest | 7022PRO-MC-C | FDA UDI | Class I | Active |
| Forest | 9073INT-C | FDA UDI | Class I | Active |
| Forest | 4987FE | FDA UDI | Class I | Active |
| Forest | 5355G | FDA UDI | Class I | Active |
| Forest | 1091INT-DURR | FDA UDI | Class I | Active |
| Forest | 9078T | FDA UDI | Class I | Active |
| Forest | 3386UC-C | FDA UDI | Class I | Active |
| Forest | 9078INT | FDA UDI | Class I | Active |
| Forest | 4987SE-C | FDA UDI | Class I | Active |
| Forest | 3900INT-G | FDA UDI | Class I | Active |
| Forest | 2184BC-G | FDA UDI | Class I | Active |
| Forest | 7023PRO-MC-G | FDA UDI | Class I | Active |
| Forest | 5355 | FDA UDI | Class I | Active |
| Forest | 7010WM-C | FDA UDI | Class I | Active |
| Forest | 8601INT | FDA UDI | Class I | Active |
| Forest | 1095G | FDA UDI | Class I | Active |
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