Device Dossier

Electrode, electromyograph

Device Dossier for Electrode, electromyograph (Electrode, electromyograph, Class IIa, sponsor ACRA Regulatory Services). ARTG record, intended purpose,…

Intended purpose

A Sterile electrical conducting device designed to be inserted transcutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle like device ( a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable /lead. The EMG records the electrical signal and converts them to a readable graph format. This is a single use device

TGA Public Summary