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510(k) Data Aggregation

    K Number
    K220988
    Device Name
    EksoNR
    Manufacturer
    Ekso Bionics, Inc.
    Date Cleared
    2022-06-09

    (66 days)

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

    Ekso Bionics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations: · Individuals with multiple sclerosis (upper extremity motor function of at least one arm). • Individuals with acquired brain injury, including traumatic brain injury and 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 use of the devices are not intended for sports or stair climbing
    Device Description
    The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
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    K Number
    K200574
    Device Name
    EksoNR
    Manufacturer
    Ekso Bionics, Inc.
    Date Cleared
    2020-06-19

    (106 days)

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

    Ekso Bionics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EksoNR™ is intended to perform ambulatory functions in rehabilitations 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 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 use of the devices are not intended for sports or star climbing.
    Device Description
    The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
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    K Number
    K161443
    Device Name
    Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
    Manufacturer
    EKSO BIONICS, INC.
    Date Cleared
    2016-07-19

    (55 days)

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

    EKSO BIONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population: • 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 use of the device. The devices are not intended for sports or stair climbing.
    Device Description
    The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
    Ask a Question
    K Number
    K143690
    Device Name
    Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
    Manufacturer
    EKSO BIONICS, INC.
    Date Cleared
    2016-04-01

    (464 days)

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

    EKSO BIONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population with upper extremity motor function of at least 4/5 in both arms: - Individuals with hemiplegia due to stroke - 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 devices are not intended for sports or stair climbing.
    Device Description
    The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
    Ask a Question

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