Ekso Bionics to Submit New 510(k) for Robotic Exoskeleton Based on Regulatory Changes

Richmond, Calif.-based Ekso Bionics Holdings Inc. recently met with the U.S. Food and Drug Administration (FDA) to discuss a change to the regulatory status of the Ekso robotic exoskeleton and other similar medical devices. Based on these discussions, the company made the decision to submit a 510(k) notification for the product in December. Ekso Bionics has been allowed to continue marketing the product while the 510(k) filing is under review. The FDA is requiring Ekso Bionics to notify their customers of these changes in the form of a letter, which customers can expect to receive this week. Ekso Bionics is committed to full compliance with FDA’s medical device regulations and is working with FDA to fully address the regulatory issues stemming from the recent change in classification for powered exoskeletons.

On June 26, 2014, the FDA reclassified powered exoskeleton devices from class I to class II (a higher-risk classification). At the time, Ekso Bionics stated in a U.S. Securities and Exchange Commission filing that there was “some ambiguity” as to whether the new wording in the classification would apply to its products or not. After discussion with the agency, the company decided in conjunction with the FDA that a new filing would be necessary.

Ekso Bionics makes robotic exoskeletons, which are wearable robots to augment human mobility, strength and endurance.