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510(k) Data Aggregation

    K Number
    K201473
    Device Name
    ExoAtlet-II
    Manufacturer
    ExoAtlet Asia Co. Ltd.
    Date Cleared
    2021-07-16

    (408 days)

    Product Code
    PHL
    Regulation Number
    890.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    ExoAtlet Asia Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation under the supervision of a trained physical therapist for the following population with upper extremity motor function at least 4/5 in both arms: · Individuals with spinal cord injuries at levels T4 to L5 - · Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D) The therapist must complete a training program prior to use of the device. The device is not intended for sports or stair climbing.
    Device Description
    The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC. ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.
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