21 CFR 890.1375 — Electromyograph, Diagnostic

Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1375

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
IKNElectromyograph, Diagnostic2753rd Party
KZMDevice, Muscle Monitoring2193rd Party
OALExercise Equipment, Powered, Emg-Triggered21
Innolitics

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