In the February 24, 2015, Federal Register,
FDA issued an order classifying the powered exoskeleton into class
II for medical devices. A powered exoskeleton is identified as
"a prescription device that is composed of an external,
powered, motorized orthosis used for medical purposes that is
placed over a person's paralyzed or weakened limbs for the
purpose of providing ambulation." The order identifies the
special controls for this type of medical device, which will be
included in its classification regulation.
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