Ekso and Vodafone win 2016 Telehealth Award

HealthTechZone

Apr 7, 2017

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Indications for Use (USA)
The Ekso™ (version 1.1) and EksoGT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations:
• Individuals with hemiplegia due to stroke (upper extremity motor function 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)

• The Ekso GT™ (Version 1.2) is intended for use as gait training device to improve walking function and independence in patients with a neurological or muscular injury, illness, or weakness.
• The Ekso GT™ (Version 1.2) 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.
• The Ekso GT™ (Version 1.2) 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.
• The Ekso GT™ (Version 1.2) 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