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510(k) Data Aggregation

    K Number
    K201539
    Device Name
    Keeogo Dermoskeleton System
    Manufacturer
    B-Temia Inc.
    Date Cleared
    2020-09-09

    (92 days)

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

    B-Temia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population: Individuals with stroke who have gait deficient hip (MMT Hip >= 3) and knee strength (MMT Knee >= 2) and who are capable of standing and initiating gait movement without assistance. The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.
    Device Description
    KeeogoTM Dermoskeleton System is an ambulatory assistive device that is fitted to the lower body, and is powered at the knee. This computer-controlled orthosis provides complementary force to the knee joint to assist with: (1) knee flexion and extension in the swing phase of gait, and (2) eccentric knee control and extension in the weight bearing phase. KeeogoTM Dermoskeleton System does not move through a pre-determined pattern of movement, but rather integrates seamlessly with movements initiated by the user themselves, and provides assistance based on the detected activity.
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