Device Dossier
Stimulator, nerve locator
Device Dossier for Stimulator, nerve locator (Stimulator, nerve locator, Class IIa, sponsor Natus Neuro). ARTG record, intended purpose, GMDN category —…
- GMDN category: Stimulator, nerve locator
Intended purpose
The Dantec Device is intended for use in the clinical setting. Dantec Clavis is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into muscles in the clinical setting. Dantec Clavis provides both EMG monitoring and stimulation functions in a single, hand-held device, and assists the physician during needle electrode examinations in the treatment of neuromuscular diseases such as Dystonia, Strabismus, Essential Tremor, Spasticity, and Temporomandibular Dysfunction. The target patient population is the pediatric and adult patient population with neuromuscular disease. This device is used in clinical settings by skilled physicians trained in electrophysiology and the specialty of neuromuscular diseases, including Neurologists and Physiatrists.