21 C.F.R. § 890.1375 Diagnostic electromyograph.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart B—Physical Medicine Diagnostic Devices
§ 890.1375 Diagnostic electromyograph.
