Device Category Dossier

Electrode, electromyograph

Device Category Dossier for Electrode, electromyograph. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Electromyography needle electrodes are designed for detection of bioelectrical signals during EMG examinations, with specialised variants featuring an open lumen that allows simultaneous recording of spontaneous EMG activity and intramuscular injection of botulinum toxin. These devices are intended for injection of botulinum toxin into muscle whilst recording electromyography activity , with indicated use across children aged 2 years, adolescents aged 12 through 21, and adults aged 22 and up.