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510(k) Data Aggregation

    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
    IPF,GZJ
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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).

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the DT-1200 series device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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