title: Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for 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 transcranial magnetic stimulator for 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: D004869:Equipment Safety / Q000145:classification*; D006261:Headache / Q000628:therapy*; D006801:Humans; D062307:Medical Device Legislation; D050781:Transcranial Magnetic Stimulation / Q000145:classification* / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence