Device Dossier

Ambulation exoskeleton, clinical

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

Intended purpose

The Ekso Bionics Indego is a powered lower limb orthosis which fits to the lower limbs and trunk of the user. Indego is intended to enable individuals with lower-limb weakness or paralysis to perform ambulatory functions in a clinical or personal use setting 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 use of Indego. The Indego is not intended for sports or stair climbing.

TGA Public Summary