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Sign in to claim this brandSilver Fox Corporation Limited
US
Last updated May 23, 2026
What Silver Fox Corporation Limited makes
Silver Fox Corporation Limited manufactures examination/treatment tables powered by line current for clinical use, multi-modality physical therapy systems designed for professional healthcare settings, and surgical/procedural instrument trolleys for procedural rooms. Their portfolio also includes room humidifiers for controlled humidity in medical environments and general-purpose stools or chairs for clinical examination spaces.
The company’s devices are regulated under FDA classifications, including Class I and Class II, with submissions recorded via 510(k) and UDI registries. Products are listed under US FDA oversight, and the manufacturer operates from 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 Silver Fox Corporation Limited manufacture?
Silver Fox Corporation Limited produces a range of medical devices primarily used in clinical and procedural settings. Their portfolio includes examination/treatment tables powered by line current, multi-modality physical therapy systems for professional healthcare use, surgical/procedural instrument trolleys, room humidifiers for maintaining controlled humidity in medical environments, and general-purpose stools or chairs for examination spaces. These devices are designed to support diagnostic, therapeutic, and procedural workflows in healthcare facilities.
Where is Silver Fox Corporation Limited based, and how does that affect its regulatory oversight?
Silver Fox Corporation Limited is based in the United States. Since the company operates within the US, its devices fall under the regulatory authority of the FDA. The FDA classifies their products as either Class I or Class II, depending on the risk and intended use, and requires compliance with US regulatory pathways such as the 510(k) premarket notification process and UDI (Unique Device Identification) registration to ensure traceability and safety.
Which regulatory registries list Silver Fox Corporation Limited’s devices, and why?
Silver Fox Corporation Limited’s devices are listed in the FDA’s 510(k) registry and the UDI (Unique Device Identification) system. The 510(k) registry tracks submissions for devices that require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, particularly for Class II devices. The UDI system ensures each device can be uniquely identified throughout its lifecycle, improving patient safety, recall management, and regulatory compliance by standardizing identification across healthcare settings.
How are Silver Fox Corporation Limited’s devices classified by the FDA, and what does that mean for their regulation?
Silver Fox Corporation Limited’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may only require general controls like good manufacturing practices (GMP). Class II devices involve moderate risk and require special controls beyond general controls, such as performance standards or post-market surveillance, to ensure their safety and effectiveness. The classification determines the regulatory pathway and compliance requirements each device must meet before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- EUDAMED SRN
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Catalogue (126)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| silverfox | 3020B | FDA UDI | Class I | Active |
| silverfox | 3020A | FDA UDI | Class I | Active |
| silverfox | F-803 | FDA UDI | Class I | Active |
| silverfox | F-821A | FDA UDI | Class I | Active |
| silverfox | 1041 | FDA UDI | Class I | Active |
| silverfox | 2212A | FDA UDI | Class II | Active |
| silverfox | 1003 | FDA UDI | Class I | Active |
| silverfox | F-381 | FDA UDI | Class I | Active |
| silverfox | 2214A | FDA UDI | Class II | Active |
| silverfox | F-315B | FDA UDI | Class I | Active |
| silverfox | F-300A | FDA UDI | Class I | Active |
| silverfox | 1030 | FDA UDI | Class I | Active |
| silverfox | F-314B | FDA UDI | Class I | Active |
| silverfox | 2251A | FDA UDI | Class II | Active |
| silverfox | F-314A | FDA UDI | Class I | Active |
| silverfox | F-319B | FDA UDI | Class I | Active |
| silverfox | F-801C | FDA UDI | Class I | Active |
| silverfox | 2285 | FDA UDI | Class II | Active |
| silverfox | 2246DB | FDA UDI | Class II | Active |
| silverfox | F-365 | FDA UDI | Class I | Active |
| silverfox | F-367A | FDA UDI | Class I | Active |
| silverfox | 2236 | FDA UDI | Class II | Active |
| silverfox | 1071 | FDA UDI | Class I | Active |
| silverfox | 1066 | FDA UDI | Class I | Active |
| silverfox | 2221D | FDA UDI | Class II | Active |
| Electric Wheelchair, Model: 9000N | K221799 | FDA 510(k) | Class II | Active |
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