Hyundai Motor Company’s X-ble MEX exoskeleton has received Class III medical device approval from South Korea’s Ministry of Food and Drug Safety, as the manufacturer also seeks certification from the United States.
Hyundai describes the X‑ble MEX, which received South Korean approval in November, as “a medical wearable robot developed by Hyundai Motor Company’s Robotics Lab. Designed to assist individuals with limited mobility, the device supports lower-limb muscle activation and joint movement for those who face difficulties walking. The device wraps around the legs and pelvis, combining the strength of metal with ergonomic design to naturally augment the wearer’s movements.”
The company said the device — which can be worn as its user is sitting in a wheelchair — is “lightweight and slim, offering excellent comfort. It supports a range of movements — walking, standing, turning, and climbing stairs — and is regarded as a highly effective tool in rehabilitation settings.”
The X‑ble MEX’s Class III certification defines the device as an advanced medical robot that can be used by people living with paralysis, as well as patients affected by stroke. The exoskeleton can be used to correct gait and to support mobility rehabilitation.
“This milestone is expected to significantly expand its application in clinical environments, paving the way for broader utilization in medical rehabilitation,” Hyundai said of the Class III certification. “This project is part of Hyundai Motor Company’s ongoing effort to make its robotics-based social contribution initiatives more widely understood and accessible. Guided by the brand vision of ‘Progress for Humanity,’ Hyundai continues to evolve into a smart mobility solutions provider — working to create a world where everyone can move freely, without discrimination.”
Image courtesy Hyundai Motor Company.
