Device Dossier
Electrode, electromyograph
Device Dossier for Electrode, electromyograph (Electrode, electromyograph, Class IIb, sponsor Biomedico). ARTG record, intended purpose, GMDN category —…
- GMDN category: Electrode, electromyograph
Intended purpose
Electromyography (EMG) Needle Electrode designed for detection of bioelectrical signals during EMG examinations. In the specific case of Hypodermic Monopolar Electrodes, these are used to inject medicines (botulinum toxin) under electromyographic (EMG) guidance. The needle equipped with an open lumen allows the simultaneous recording of spontaneous EMG activity and the intramuscular injection of botulinum toxin. The devices must be used in a hospital environment by specialized medical personnel.