Metame Health, Inc.

Metame Health, Inc. specializes in software applications for mindfulness and non-clinician-led behavioural therapy. These devices are designed to help users manage stress, emotional regulation, and mental well-being through structured digital interventions. The primary category is mindfulness/behavioural therapy software, which does not require clinician oversight.

Metame Health, Inc. is headquartered in the United States. The company’s regulatory filings and device classifications align with US medical device standards, including FDA requirements.

Metame Health, Inc.’s devices fall under Class II classification in the US. This classification applies to software-based behavioural therapy tools that, while not invasive or high-risk, still require premarket review to ensure safety and effectiveness. Class II devices typically undergo the FDA’s 510(k) premarket notification process and must comply with the Unique Device Identifier (UDI) system to ensure traceability and regulatory oversight.

Metame Health, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorised medical devices in the US, including software-based behavioural health tools, to ensure compliance with regulatory requirements and public transparency.

The 510(k) premarket notification process is used for Class II devices like those from Metame Health, Inc. because it demonstrates that the software-based behavioural therapy tools are substantially equivalent to legally marketed predicate devices. This means they share the same intended use and technological characteristics, ensuring they meet FDA safety and performance standards without requiring the more rigorous premarket approval (PMA) process reserved for higher-risk Class III devices.