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510(k) Data Aggregation

    K Number
    K133979
    Device Name
    TENS
    Date Cleared
    2014-08-26

    (243 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNMAS (H.K.) TRADING LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is intended to be used for temporary relief of pain associated with sore and aching muscle in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    The TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. The TENS consists of LCD, Control Key, Switch, Battery, Output jack and USB port, its accessories includes electrode, electrode cable, USB wire and Battery charger. Only the electrode pads cleared in submission, K092546, are to be used with this device The proposed device has six models: SM9066, SM9088, SM9090, SM9098, SM9128 and SM9198. The six models have the same design principle and functional components, including battery, LCD, Control Key, Switch, channel number and USB port and accessories. The difference between the six models specifically expressed in the battery specification, LCD dimension, the position of Control key, Switch, and USB port on the proposed device, PCB(Printed Circuit Board) dimension and the number of Output jack numbers.
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