Vibratory counter-stimulation device. Medical equipment (ICS 11.040)

Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device (2 pages, in English)

The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device 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 vibratory counter-stimulation device'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.