Cyberdyne, a Japanese robotics and technology company, has received an EC certificate from German safety monitoring agency TÜV Rheinland for its robot suit, called Hybrid Assistive Limb (HAL), which is intended for the lower body rehabilitation.
The robotic suit, which was certified as a medical device, is designed to enable patients with leg disabilities to walk.
This certification paves way to sell the device in other parts of Europe.
According to the company, the robot can improve, supplement and expand physical capability in a person.
Equipped with sensors, this 'cyborg-type robot', which can be worn as an exoskeleton, detects bioelectrical signals beneath the skin sent by the brain to a muscle through a nerve.
Once it captures the signals, HAL moves the robotic joint simultaneously with the wearer's muscle movement, enabling the patient to move, climb stairs and run.
In case the device is not able to detect bio-electrical signals due to problems in the central nervous system or in the muscles, it is equipped with autonomous control system.
In the automatic mode, HAL can run and the battery may last for three hours depending on the usage.
The HAL received EC certification only after the firm made several improvements in safety and other aspects.
The company now intends to begin clinical studies in Europe.
Cyberdyne will export about 12 HAL robots to a German hospital group Bergmannsheil and about 100 individuals with leg disabilities are expected to take part in a clinical trial.
The company also plans to launch HAL robot as a medical device in the US and Asia.