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510(k) Data Aggregation

    K Number
    K151034
    Device Name
    PainKARE
    Manufacturer
    TrioWave Technologies
    Date Cleared
    2015-11-21

    (218 days)

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

    TrioWave Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PainKARE is indicatied for Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities.
    Device Description
    PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy. PainKARE's Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
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