§ 882.5889 Electrical tongue nerve stimulator to treat motor deficits.

(a) Identification. An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits. (b) Classification. Class II (special controls). The special controls for this device are: (1) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical, mechanical, and thermal safety of the device. (3) Non-clinical performance testing must characterize the electrical stimulation parameters of the device. (4) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users as part of cybersecurity review. (5) Labeling must include: (i) A detailed summary of the device's technical parameters; (ii) Instructions for use; (iii) Cleaning, storage, and charging instructions; and (iv) Disposal instructions.