Device Dossier
Ambulation exoskeleton, clinical
Device Dossier for Ambulation exoskeleton, clinical (Ambulation exoskeleton, clinical, Class IIa, sponsor Involution Healthcare). ARTG record, intended…
- GMDN category: Ambulation exoskeleton, clinical
Intended purpose
ExoAtlet-II is a battery-powered bionic lower limb orthosis. It includes a wearable exoskeleton made of metal with electric motors, mechanical actuators, controls and an on-board computer with proprietary software used to operate the different training modes of ExoAtlet-II. It is fitted to the lower limbs and trunk of the patient typically over the patient’s clothing. ExoAtlet-II is intended to assist patients with lower-limb mobility impairment or paralysis arising from neurological or muscular injury, disease or disability to perform ambulatory functions by helping to facilitate the restoration or improvement of ambulation for the patient. ExoAtlet-II has a number of different training modes which are customisable for each patient to assist the patient with: • Walking – as a gait training device to improve walking function and stability. • Walking-in-place. • Sit-to-standing. • Standing-to-sit down. • Rotation. • Stair-climbing (ascend and descend). ExoAtlet-II is intended to be used by multiple patients (and can be adjusted for patients of different size) in a clinical setting or in a personal or home use setting, provided that in each case it is operated with the assistance of a specially trained clinician or companion. Only individuals who participate in and successfully pass the clinical training program requirements are allowed to operate, or assist in the operation of, ExoAtlet-II. ExoAtlet-II is not intended for running or sports use.