Indications for Use (USA)
Ekso, and EksoGT, and EksoNR are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations:
- Individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor functions of at least 4/5 in at least one arm).
- Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)
- Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms)
- The therapist must complete a training program prior to the use of the device. The devices are not intended for sports or stair climbing.
Source: FDA Part 21 CFR
Indications for Use (EU)
- EksoNR is intended for use as a gait training device to improve walking function and independence in patients with a neurological or muscular injury, illness, or weakness.
- EksoNR is designed to be used in a controlled clinical or non-clinical setting under supervision of Ekso Certified Physical Therapist (or equivalent medical professional) and operated by a Trained Spotter.
- EksoNR is a device intended to help facilitate the restoration or improvement of ambulation for its pilots. The device is intended to serve multiple pilots over the duration of its life.
- EksoNR is used 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.
Source: Intended Use – Council Directive 93/42/EEC, Annex II