Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton; Republication

The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled "Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton" that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.