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510(k) Data Aggregation

    K Number
    K053284
    Device Name
    MAGBODY DT-600
    Manufacturer
    DURTECH SYSTEM CORP.
    Date Cleared
    2006-03-10

    (105 days)

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

    DURTECH SYSTEM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS). As a EMS device, DT-600 is indicated for the following conditions: - · Relaxation of muscle spasms As a TENS device, the DT-600 is indicated for the following conditions: - · For symptomatic relief of chronic intractable pain.
    Device Description
    The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).
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    K Number
    K053285
    Device Name
    MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
    Manufacturer
    DURTECH SYSTEM CORP.
    Date Cleared
    2006-01-05

    (41 days)

    Product Code
    IPFGZJ
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DURTECH SYSTEM CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DT-1200 series is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS). As a EMS device, (available for DT-1200, DT-1200M and DT-1200PM) the DT-1200 is indicated for the following conditions: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a TENS device, (available for DT-1200T and DT-1200T and DT-1200PT) the DT-1200 is indicated for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain
    Device Description
    The DT-1200 series is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS).
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