GOLDENGAIT LTD

GoldenGait Ltd specializes in powered standard treadmills, specifically designed for clinical and rehabilitation settings. Their devices, such as the GaitBetter and GaitBetter System, are primarily used for gait training and mobility assessment in controlled environments. These treadmills are tailored to support therapeutic and recovery processes.

GoldenGait Ltd is headquartered in Israel. The company’s location influences its regulatory compliance, particularly for devices marketed in the EU and the US, where they must adhere to local requirements like EUDAMED registration and FDA UDI listing.

GoldenGait Ltd’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Additionally, their products are listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance with US regulatory standards.

GoldenGait Ltd’s devices fall under EU Class I classification, which is the lowest risk category for medical devices in the European Union. This classification applies to products like powered treadmills intended for non-invasive use in gait training and mobility assessment, where the risk to patient safety is minimal. Classification determines regulatory requirements, and Class I devices typically undergo less stringent scrutiny than higher-risk categories.