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510(k) Data Aggregation

    K Number
    K070299
    Device Name
    EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
    Manufacturer
    EZFIT TECHNOLOGY INC.
    Date Cleared
    2007-07-16

    (166 days)

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

    EZFIT TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Transcutaneous Electrical Nerve Stimulation, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for · symptomatic relief and management of chronic intractable pain. For Powered heating therapy , ezFit Digital Heating TENS (Model No .; HR-661/ UC-101) is intended for - · Temporary relief of minor aches and pains and muscle spasms
    Device Description
    ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) ( Transcuntaneus Electrical Nerve Stimulator) is designed for symptomatic relief and management of chronic intractable pain. ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is of independent two channels output (double output), the user can choose to use a single channel connecting to two electrode pads or using both channels with four electrode pads simultaneously. With large LCD panel. It is powered by 3.6V(1.2V x 3)Ni-H Rechargeable Batteries or AC-DC adaptor. The ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is a TENS (Transcuntaneus Electrical Nerve Stimulator) that employs a combination application of previously well known electrical and temperature treatment modalities for pain relief and rehabilitation. The system is based on a combination of thermal transfer (Powered heating pads - 21 CFR 890.5740) and conventional TENS - 21 CFR 882.5890) therapy. When used in either Compress heat function only or Compress heat function plus TENS , An electronically controlled thermoelectric electrode pads can provide automatic thermal control with a Range of 36℃ - 42℃ . The Dual output can be adjusted to provides thermal heat to the skin between 40 and 42 °C for at least 10 minutes as therapeutic heating. This automatic thermal control mechanism also avoid skin from thermal injury.
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