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510(k) Data Aggregation

    K Number
    K142686
    Device Name
    StimPad OTC
    Manufacturer
    AEMED, INC.
    Date Cleared
    2014-12-18

    (87 days)

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

    AEMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StimPad OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household work activities.
    Device Description
    The StimPad® OTC is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad® OTC is powered by a replaceable, 3 volt Lithium battery (CR2032). The StimPad™ device has pre-programmed settings for frequency (ie, 7.1 Hz), pulse width (ie, 47 milliseconds for the low, medium and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms) and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is prevented from modifying this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).
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    K Number
    K071120
    Device Name
    AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
    Manufacturer
    AEMED, INC.
    Date Cleared
    2008-03-13

    (328 days)

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

    AEMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StimPad™ System is a transcutaneous electrical nerve stimulator (TENS) device intended for the delivery of electrical stimulation applied through the surface of patient's skin for the treatment of chronic intractable pain, and post-traumatic acute pain. The StimPad™ can be used for self treatment as well as for the treatment of others. It is a prescription use device. The StimPad™ System is indicated for the symptomatic relief of chronic intractable pain, and post-traumatic acute pain.
    Device Description
    The StimPad™ is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad™ is powered by a self-contained three-volt lithium battery. The StimPad™ device has pre-programmed settings for frequency (i.e. 7.1 Hz), pulse width [i.e. 47 milliseconds for the low, medium, and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms] and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is not allowed to modify this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort). A three-volt lithium battery powers the StimPad™. The life of the battery varies with the frequency of activation, repetition and ambient temperature conditions. The battery is not replaceable. Once the battery is depleted, the device ceases to function and should be disposed or returned to the manufacturer.
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