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510(k) Data Aggregation

    K Number
    K113724
    Device Name
    ELECTROPULSE-COSMETIC
    Manufacturer
    PAIN RELIEF TECHNOLOGIES
    Date Cleared
    2012-02-15

    (58 days)

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

    PAIN RELIEF TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use. Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.
    Device Description
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    K Number
    K062532
    Device Name
    ELECTROPULSE - LOW BACK PAIN
    Manufacturer
    PAIN RELIEF TECHNOLOGIES
    Date Cleared
    2007-02-09

    (165 days)

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

    PAIN RELIEF TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for the temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise, or normal household and work activities. Relaxing muscles and relieving minor aches and pains. Emits energy at near infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
    Device Description
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    K Number
    K051128
    Device Name
    ELECTROPULSE
    Manufacturer
    PAIN RELIEF TECHNOLOGIES
    Date Cleared
    2006-03-10

    (311 days)

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

    PAIN RELIEF TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS The symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain. Vibration Relaxing muscles and relieving minor aches and pains. Heat Lamp Emits energy at infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
    Device Description
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