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Heat-sensitive Moxibustion as a Traditional Chinese Medicine Therapy for Chronic Obstructive Pulmonary Disease Combined with Insomnia
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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.
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