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Quarterly Reports

Filter Filings:
Date Form Description View As Pages
08/07/17 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-10.46
EX-10.47
EX-10.48
EX-31.1
EX-31.2
EX-32.1
EX-32.2
57
05/09/17 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
34
11/09/16 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-10.38
EX-31.1
EX-31.2
EX-32.1
EX-32.2
43
08/03/16 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
35
05/10/16 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
35
11/09/15 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
37
08/12/15 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
36
05/11/15 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
34
11/12/14 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
42
08/08/14 10-Q Quarterly report pursuant to Section 13 or 15(d)
Documents
EX-31.1
EX-31.2
EX-32.1
EX-32.2
41
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    ©2011-2019 Ekso Bionics Privacy Policy Cookie Declaration

    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