BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DYNA T-2000 PHYSICAL THERAPY SYSTEM

    K Number: K955808 · Decision Nov 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    682

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    Basic Information

    Device Name
    DYNA T-2000 PHYSICAL THERAPY SYSTEM
    K Number
    K955808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5250
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermia, Inc.
    Date Received
    December 22, 1995
    Decision Date
    November 3, 1997
    Product Code
    IMB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMB Cabinet, Moist Steam

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