Cerebrotech Medical Systems, Inc.

Cerebrotech Medical Systems, Inc. specialises in bioelectrical body composition analysers. These devices use bioelectrical impedance technology to assess fluid status and body composition, such as their example products: the Cerebrotech Fluids Monitor and the Visor System. The focus is on non-invasive monitoring of hydration and body composition metrics.

The company is headquartered in the United States. This location aligns with its regulatory submissions and compliance requirements under FDA guidelines, ensuring its devices meet US-specific standards for safety and performance.

Cerebrotech’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries track authorised medical devices to ensure traceability and compliance with US regulatory processes, particularly for Class II devices.

The company’s devices fall under Class II classification by the FDA. This classification is typically assigned to devices with moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. The classification influences regulatory pathways, such as the 510(k) process, which demonstrates substantial equivalence to a predicate device.