Cyberdyne, Inc.

Cyberdyne, Inc. specializes in neuro-controlled ambulation exoskeletons, specifically designed for medical applications. Their portfolio focuses on devices that assist users in walking or standing through motorized support, controlled by neural signals. These are primarily lower limb exoskeletons, such as the HAL for Medical Use and its variants, aimed at mobility assistance or rehabilitation.

Cyberdyne, Inc. is based in the United States. As a US-based manufacturer, its medical devices are subject to FDA regulations. The company’s products fall under Class II classification, meaning they carry a moderate risk and require compliance with FDA requirements, including 510(k) premarket notifications and UDI (Unique Device Identification) registrations to ensure traceability and safety.

Cyberdyne, Inc.’s medical devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and UDI (Unique Device Identification) registrations. These listings ensure transparency and compliance tracking for devices like the HAL for Medical Use and its lower limb variants, which are authorised under these frameworks.

Cyberdyne, Inc.’s devices are classified as Class II medical devices in the US. This classification is based on their intended use—providing neuro-controlled ambulation support—which carries moderate risk. Class II devices require compliance with specific FDA controls, such as 510(k) clearance for substantial equivalence to a predicate device and UDI registration to maintain regulatory oversight and ensure patient safety.