VIRTUALIS

Virtualis specializes in software and systems for biomechanical function analysis and posturography. Their devices include virtual reality-based rehabilitation tools, such as the DVA VR and Motorway Simulation, as well as posturography platforms like the Sway Referenced Visual Environment. These tools are designed for assessing and improving motor coordination, balance, visual adaptation, and specific physiological functions like eye-hand coordination and spinal mobility.

Virtualis is based in the United States, where its devices are regulated under applicable FDA standards. Since the company operates within the US, its products fall under FDA oversight, including classification under Class I (generally low-risk) and Class II (moderate-risk) categories, depending on their intended use and potential risks.

Yes, Virtualis’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.

Virtualis’s devices are classified under FDA’s Class I (for low-risk items like some rehabilitation software) and Class II (for moderate-risk items like posturography systems). Classification depends on factors like the device’s purpose, potential risks, and intended use—such as assessing balance or motor function—rather than the company itself.

Virtualis’s tools leverage virtual reality (VR) and simulation platforms to create immersive environments for rehabilitation and assessment. For example, devices like SpineVR or StroopVR combine VR with biomechanical metrics to evaluate and train specific functions—such as spinal mobility or cognitive-motor coordination—unlike traditional non-VR systems that may rely solely on static measurements or physical equipment.