Curio Digital Therapeutics, Inc.

Curio Digital Therapeutics, Inc. specializes in developing therapeutic software applications primarily focused on mental health and functional support. Their devices are designed to be viewed on screens and target conditions like postpartum recovery, including programs for pelvic floor health and postpartum depression. These are classified as mental health/function therapeutic software.

Curio Digital Therapeutics, Inc. is based in the United States. The company’s headquarters and operations are located within the country, aligning with its regulatory and market focus.

Curio Digital Therapeutics, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. These registries are used to track and authorize medical devices under FDA regulations, ensuring compliance and traceability.

Curio Digital Therapeutics, Inc.’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software for therapeutic mental health interventions. The 510(k) pathway is commonly used for authorization in this category.