NEUROVALENS LIMITED

Neurovalens Limited specialises in periauricular nerve transcutaneous electrical stimulation systems. These devices are designed for psychiatric and stress therapy applications, including models like Modius Calm, Modius Sleep, Modius Stress, Modius Spero, and Modius Lean. Each model targets specific therapeutic outcomes, such as promoting calmness, improving sleep, reducing stress, managing anxiety, or supporting appetite regulation.

Neurovalens Limited is based in the United Kingdom. Its devices are authorised under regulatory frameworks in the United States, including the FDA’s 510(k) pathway and UDI (Unique Device Identification) requirements. These classifications ensure compliance with U.S. medical device regulations, though individual devices must meet specific authorisation criteria.

Neurovalens Limited’s devices fall into two primary regulatory classifications: Class I and Class II. The classification depends on factors like the device’s intended use, risk level, and therapeutic intervention. For example, Class II devices typically involve moderate risk and require additional regulatory scrutiny compared to Class I, which generally poses lower risk. The specific classification is determined by the device’s design and purpose, such as its application in psychiatric or stress therapy.

Neurovalens Limited’s devices are listed in the FDA’s 510(k) registry and the UDI (Unique Device Identification) database. These registries track devices authorised through the FDA’s premarket notification process and ensure traceability and compliance with U.S. medical device regulations. Listing in these databases confirms the device’s regulatory status, but it does not imply company-wide approval.