Ekso Bionics, Inc.

Ekso Bionics, Inc. specializes in two primary categories of medical devices: programmable ambulation exoskeletons for clinical rehabilitation and shoulder continuous passive motion exercisers. Their exoskeletons, such as the EksoGT, EksoUE, and Indego, are designed to assist patients with mobility challenges, including gait training and independent walking support. The Indego system also includes a mobile app for therapy control, while devices like the Ekso Walker focus on structured clinical rehabilitation.

Ekso Bionics, Inc. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s 510(k) and UDI databases, indicating they have undergone the necessary regulatory processes for market authorization in the US. Additionally, some of their devices are recorded in the EU’s eudamed registry, reflecting compliance with European medical device regulations.

Ekso Bionics’ devices are listed in three key registries: the FDA’s 510(k) and UDI databases (for US authorization) and the EU’s eudamed registry (for EU compliance). These listings confirm that the devices have met the necessary regulatory requirements for their respective markets. For healthcare providers, clinicians, or regulators, checking these registries ensures the devices are authorized and can be trusted for clinical or patient use.

Ekso Bionics’ devices fall under Class I and Class II (including Class IIa) classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II and Class IIa devices involve higher risk and require additional regulatory scrutiny, such as special controls or performance standards. The classification determines the level of oversight and documentation required during the authorization process, ensuring patient safety and device efficacy.

Ekso Bionics’ exoskeletons, like the EksoGT and Indego, are designed for ambulation and mobility assistance, helping patients regain or maintain walking ability in clinical or home settings. In contrast, their shoulder continuous passive motion devices, such as the Indego system, focus specifically on improving shoulder mobility through controlled, passive range-of-motion exercises. While exoskeletons support full-body movement, shoulder devices target isolated joint rehabilitation.