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510(k) Data Aggregation

    K Number
    K123746
    Device Name
    AMES THERAPY DEVICE
    Date Cleared
    2013-05-24

    (169 days)

    Product Code
    Regulation Number
    890.1925
    Why did this record match?
    Product Code :

    IKK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.
    Device Description
    The AMES Therapy Device is an electromechanical physical therapy device that combines 3 motion assemblies (one for the ankle, one for the wrist, and one for the thumb-and-fingers), 5 therapeutic vibrators, and a visual feedback unit, all contained in one device. The patient is seated in a separate conventional chair or wheelchair so that the appropriate limb can be attached to the AMES Therapy Device for therapy. The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen. Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefitting from the therapy. The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.
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