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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM

    K Number: K053285 · Decision Jan 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM
    K Number
    K053285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Durtech System Corp.
    Date Received
    November 25, 2005
    Decision Date
    January 5, 2006
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Durtech System Corp.

    K Number Device Name
    K053284 MAGBODY DT-600