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510(k) Data Aggregation

    K Number
    K124055
    Device Name
    T1040 AKA AURAWAVE
    Manufacturer
    ENDURANCE THERAPEUTICS
    Date Cleared
    2013-07-19

    (200 days)

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

    ENDURANCE THERAPEUTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4. To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3. To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto1 or Auto 4. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1, Auto 2, Auto 3, or Auto 4. Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.
    Device Description
    Not Found
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    K Number
    K060846
    Device Name
    THERAPEUTIC MASSAGE COMPANION
    Manufacturer
    ENDURANCE THERAPEUTICS
    Date Cleared
    2007-12-03

    (615 days)

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

    ENDURANCE THERAPEUTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4 To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3 To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto 4 Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2
    Device Description
    The T1040 is a portable; battery powered (4.5 VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. Independent channel (two pads) that effectively transfers your desired choice of preprogrammed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. A garment belt is used to hold the electrode pads to treat the lower back muscles. There are 10 modes of operation, 6 manual and 4 automatic.
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