Innovative Neurological Devices, LLC

Innovative Neurological Devices, LLC specializes in periauricular nerve transcutaneous electrical stimulation systems. These devices are primarily used for psychiatric and stress-therapy applications, targeting nerve pathways near the ear to support therapeutic interventions for specific neurological and psychological conditions. Their flagship product, Cervella, exemplifies this category.

The company is headquartered in the United States. While the exact location isn’t specified, its regulatory filings and listings confirm its operational base within the country.

The company’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are used to track and authorise medical devices under U.S. regulatory pathways, ensuring compliance and transparency for healthcare providers and regulators.

The devices manufactured by Innovative Neurological Devices, LLC fall under Class II and Class III classifications. Class II devices typically require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device, while Class III devices—often higher-risk—require premarket approval (PMA) to ensure safety and effectiveness before market entry. These classifications determine the regulatory pathway for authorisation.