title: Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache 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 transcutaneous electrical nerve stimulator to treat headache 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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006261:Headache / Q000628:therapy; D006801:Humans; D062307:Medical Device Legislation; D004561:Transcutaneous Electric Nerve Stimulation / Q000145:classification* / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence