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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