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510(k) Data Aggregation

    K Number
    K062631
    Device Name
    MYOMO E100
    Manufacturer
    Date Cleared
    2007-04-12

    (219 days)

    Product Code
    Regulation Number
    890.1375
    Why did this record match?
    Product Code :

    OAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Myomo e100 is indicated for use by stroke patients undergoing rehabilitation to facilitate the following: . Stroke rehabilitation by muscle re-education . Maintaining or increasing range of motion .
    Device Description
    The Myomo e100 is an electromechanically powered device intended to facilitate movement and increase range of motion for stroke patients. This device would be included as part of prescribed physical therapy to enable stroke patients to exercise that would otherwise be unable to independently do so. The Myomo e100 is an automatic strength amplifier using the detected electromyograph (EMG) as an indication of residual muscle strength. In the case of a patient who is unable to move his/her arm, the addition of strength amplification allows him/her to perform standard physical therapy exercises. The Myomo e100 is available in left and right arm configurations. Foam pad inserts of various shapes are provided for fitting the brace for individual patients. Placement of the EMG sensors is configured for the individual patient allowing placement on either the tricep or bicep depending on the prescribed exercise. Optional adjustments for bicep and tricep gain are set and stored as part of the customization. As pictured in Figure 1, adjustable straps are used to attach the brace to the arm. Once the brace is properly fitted to the arm the Myomo e100 is turned on using the "Control User Interface". The EMG signals are calibrated in the resting position and then the brace is ready for operation. The battery pack attaches to the "Control User Interface" and is not in contact with the patient. The prescribing health care provider incorporates use of the Myomo e100 as part of a patient's physical therapy regimen. Progress can be monitored through the prescribed therapy using a goniometer, Fugl-Meyer testing, or other conventional evaluation techniques. The Myomo e100 consists of three main elements: - Brace: provides support for the forearm during lift. 4.1 - 4.2 EMG Sensors: B & L Electrodes - Control User Interface: provides the signal processing function and the motor 4.3 mechanism and controls for operation of the Myomo e100.
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