Medical devices; physical medicine devices; classification of the powered exoskeleton. Final order.
: The Food and Drug Administration (FDA) is classifying the powered 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 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.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D009989:Orthotic Devices / Q000145:classification*; D010810:Physical and Rehabilitation Medicine / Q000145:classification* / Q000295:instrumentation*; D014481:United States; D016138:Walking