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510(k) Data Aggregation

    K Number
    K182090
    Device Name
    AposTherapy System
    Date Cleared
    2018-11-16

    (106 days)

    Product Code
    Regulation Number
    890.3475
    Why did this record match?
    Applicant Name (Manufacturer) :

    APOS Medical Assets Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AposTherapy System is intended to be used by trained professionals for adjusting the distribution of weight/force(s) that is being applied to a lower limb. The AposTherapy System is intended for patients with knee osteoarthritis, to help temporarily reduce knee pain and improve lower extremity function during activities of daily living.
    Device Description
    The AposTherapy System consists of a pair of shoe-like uppers with two convex units (Pertupods) on the sole of each shoe, a screw fixation mechanism for securely attaching the Pertupod to the track and, if required, soft spacers, weight discs, hard spacers, and wedge spacers. Legally marketed gait analysis software may be used by practitioners to help inform their calibration of the biomechanical device, but the software is not supplied with the device. The device is worn over socks, so it has no direct contact with the patient. Based on a preliminary evaluation of pain, function, and quality of life, a personalized therapy program is created to meet the patient's treatment needs using the personally calibrated device. Practitioners may use basic, legally marketed gait analysis software (not provided with the device) to collect measurements from various movements (e.g., velocity, step length, single limb support) as part of the treatment program. The patient's progress is assessed periodically; the device is then further adjusted and the therapy program updated as needed to achieve the pre-defined goals. The device is intended to be worn only during the time scheduled by the practitioner (e.g., 30 minutes a day).
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