Section 882.5892 - External vagal nerve stimulator for headache(a)Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.(b)Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge ([MICRO]C) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.(2) Software verification, validation, and hazard analysis shall be performed.(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).(5) The labeling must include:(i) Instructions for proper use of the device, including placement of the device on the patient; and(ii) Instructions on care and cleaning of the device. 82 FR 61169 , Dec. 27, 2017