Appliedvr

Appliedvr specializes in virtual reality systems focused on pain relief. Their portfolio includes immersive therapy solutions designed to help manage acute and chronic pain in clinical environments. These devices are tailored for medical use, leveraging VR technology to provide non-pharmacological pain management options.

Appliedvr is headquartered in the United States. Since their devices are authorised under U.S. regulations, they operate primarily within the FDA’s jurisdiction. Their products are subject to U.S. medical device compliance requirements, including classification and authorisation processes specific to the FDA.

Appliedvr’s devices fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s products are authorised through the 510(k) pathway, which demonstrates substantial equivalence to a legally marketed predicate device.

Yes, Appliedvr’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the medical device supply chain, allowing regulators, healthcare providers, and patients to identify and track specific devices. Listing in the UDI database is a requirement for Class II devices authorised via the 510(k) process.

The FDA categorises medical devices based on risk levels, with Class II devices requiring special controls to mitigate moderate risks. Appliedvr’s pain relief VR systems are classified as Class II because they involve immersive technology that interacts with patients in clinical settings, where improper use or malfunction could pose risks such as disorientation, motion sickness, or unintended physiological responses. These controls ensure the devices are safe and effective for their intended use while balancing regulatory oversight with innovation.