Device Dossier

Ambulation exoskeleton, clinical

Device Dossier for Ambulation exoskeleton, clinical (Ambulation exoskeleton, clinical, Class IIa, sponsor ACRA Regulatory Services). ARTG record,…

Intended purpose

Battery powered bionic wearable robot / exoskeleton system with SmartAssist software intended to be used • by people with lower-extremity paralysis or weakness to get them standing up or walking; • as gait training device to improve walking function and independence in patients with a neurological or muscular injury, illness, or weakness; • to help facilitate the restoration or improvement of ambulation for patient; • to manipulate the legs of a patient and move them through the normal walking gait, from the sit-to-stand position and from standing back to sitting • by multiple patients over the duration of its life

TGA Public Summary