890.1375 Diagnostic electromyograph.§ 890.1375 Diagnostic electromyograph.
(a) Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
(b) Classification. Class II (performance standards).