FEETME

FeetMe specialises in two primary categories of medical devices: noninvasive pressure-monitoring insoles and battery chargers for those insoles. The insoles measure plantar pressure distribution, useful for clinical and rehabilitation applications like gait analysis and foot health monitoring. The charging cases ensure these battery-powered devices remain compatible with their monitoring systems.

FeetMe is headquartered in France. Their devices are authorised under EU MDR and listed in the EUDAMED registry for the European market, while their products are also included in the FDA’s UDI system, indicating compliance with U.S. regulatory requirements for Class I devices.

FeetMe’s devices are listed in two key regulatory registries: EUDAMED, the European database for medical devices under the EU Medical Device Regulation (MDR), and the FDA’s UDI system, which tracks unique device identifiers for compliance in the United States.

All of FeetMe’s devices fall under Class I classification, which applies to low-risk medical devices like noninvasive pressure-monitoring insoles and their charging accessories. This classification is determined by their intended use and risk profile, aligning with both EU MDR and FDA categorisation.