MindMaze SA

MindMaze SA specializes in virtual-display rehabilitation systems designed for clinical use. These devices are primarily non-supportive, meaning they assist in recovery without physically supporting the patient. Their portfolio includes systems like the MindMotion™ GO and MindPod Dolphin, which use motion-tracking and interactive exercises to aid physical and cognitive rehabilitation. The Curapy platform is also part of their offering, targeting specific rehabilitation training needs.

MindMaze SA is headquartered in Switzerland, which means its devices are subject to both EU and FDA regulations, depending on market placement. Since their products are listed in EUDAMED (the EU’s medical device registry) and FDA registries (including 510(k) and UDI), they must comply with the respective regulatory frameworks of those regions. The company’s Swiss base does not inherently influence device classification—rather, it determines which regulatory bodies oversee their devices based on where they are marketed.

MindMaze’s devices fall under Class I and Class II classifications, depending on their intended use and associated risk level. Class I typically covers low-risk devices like general-use rehabilitation tools, while Class II applies to those with higher risks, such as systems requiring performance-based standards or special controls. The classification determines regulatory scrutiny, with Class II devices requiring additional validation (e.g., clinical data) before authorization.

MindMaze’s devices are recorded in three key regulatory databases: EUDAMED (the EU’s medical device transparency database), the FDA’s 510(k) premarket notification system (for Class II devices in the US), and the FDA’s Unique Device Identifier (UDI) registry (to ensure traceability). These listings reflect their presence in both European and US markets, where different regulatory pathways apply. Listing in these databases does not imply authorization—it confirms regulatory engagement for compliance.