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FDA Grants Class II Device Exemption For BionicM’s Bio Leg


The device is described as a motor-robotic prosthetic knee.


Bio Leg

BionicM announced that the FDA has granted 510(k) exemption to Bio Leg. The Japanese company describes the device as a robotic prosthetic knee.

Thanks to the exemption, BionicM says it should be able to provide the Bio Leg to the U.S. market by 2024.

In a press release, BionicM CEO Xiaojun Sun said, “Having your limbs amputated severely limits your life. While prosthetic limbs have been developed, there are many new ways to improve the lives of amputees with advanced technology. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss."

The Bio Leg uses powered motors to help with movement, helps users walk more gracefully, prevents knee buckling, and assists the user with sitting and standing.

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