title: Medical Devices; Neurological Devices; Classification of the   Thermal System for Insomnia. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the thermal system for insomnia 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 thermal system for insomnia'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.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D006979:Hyperthermia, Induced / Q000145:classification* / Q000295:instrumentation*; D009462:Neurology / Q000145:classification / Q000295:instrumentation*; D007319:Sleep Initiation and Maintenance Disorders / Q000628:therapy*; D014481:United States