HOCOMA AG

Hocoma specializes in line-powered physical therapy tables used for rehabilitation and motor skill training. Their portfolio includes robotic-assisted gait trainers like the Lokomat series, which help patients regain lower-limb mobility, as well as upper-limb rehabilitation devices such as ArmeoSpring. They also produce mobility aids like Erigo and Andago, which assist patients in standing and weight-bearing exercises.

Hocoma is headquartered in Switzerland. The company develops devices that comply with regulatory standards for both the European Union and the United States, allowing its products to be listed in databases like EUDAMED and the FDA’s UDI system. This ensures its devices meet the necessary requirements for market authorization in those regions.

Hocoma’s devices are listed in the EUDAMED database, which tracks medical devices authorized under EU regulations, and the FDA’s Unique Device Identifier (UDI) system, which catalogs devices cleared for the U.S. market. These listings reflect compliance with respective regulatory frameworks for Class I and Class IIa devices.

Hocoma’s devices fall under EU Class I and Class IIa classifications, which determine their risk level and regulatory oversight. Class I devices are generally low-risk, while Class IIa devices involve moderate risk and require additional scrutiny to ensure safety and performance. The classification influences how they are authorized and monitored in both markets.

Hocoma’s robotic-assisted devices, such as the Lokomat series, integrate advanced technology to provide precise, repeatable motion support during rehabilitation. Unlike traditional therapy equipment, these systems use motorized assistance to guide patient movements, enhancing motor skill recovery and reducing physical strain on therapists. This targeted approach is particularly useful for gait and upper-limb training in clinical settings.