§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.

(a) Identification. A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed: (i) Electrical performance testing must validate electrical output and duration of stimulation; (ii) Battery performance testing must be performed; and (iii) Adhesive integrity testing of the electrodes must be conducted. (4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized. (5) Software verification, validation, and hazard analysis must be performed. (6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life. (7) Labeling must include the following: (i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator; (ii) A warning that the device is only for use on clean, intact skin; (iii) Information on how the device operates and the typical sensations experienced during treatment; (iv) A detailed summary of the device technical parameters; (v) A shelf life for the electrodes; (vi) Instructions for use, including placement of the device on the patient; and (vii) Cleaning instructions.