Device Dossier

Stimulator, electrical, neuromuscular, diagnostic

Device Dossier for Stimulator, electrical, neuromuscular, diagnostic (Stimulator, electrical, neuromuscular, diagnostic, Class IIa, sponsor Laborie…

Intended purpose

A stimulator that applies stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It is usually simpler in design and function than neuromuscular stimulators used for therapeutic purposes. Most diagnostic neuromuscular stimulators use external electrodes, e.g. hand-held bipolar electrodes, ring electrodes or sometimes needle electrodes, to obtain very localized activation. It is intended for neurophysiological testing, including but not limited to: Somatosensory evoked potentials, nerve conduction, sacral reflexes and pudendal nerve terminal motor latency studies.

TGA Public Summary