Device Dossier
Electrode, electromyograph
Device Dossier for Electrode, electromyograph (Electrode, electromyograph, Class IIb, sponsor AMBU). ARTG record, intended purpose, GMDN category —…
- GMDN category: Electrode, electromyograph
Intended purpose
Electromyography (EMG) Needle Electrode designed for Botulinum Toxin therapy during nerve block procedures. The Ambu Neuroline Inoject needle electrode is indicated for EMG guided injection of Botulinum Toxin for nerve block procedures.Intended Patient Population: · Children: 2 years to less than 12 years · Adolescents: aged 12 through 21 (up to but not including the 22nd birthday) · Adults: age 22 and up