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

    PMD-2000 INTERFERENTIAL STIMULATOR

    K Number: K042881 · Decision Nov 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    PMD-2000 INTERFERENTIAL STIMULATOR
    K Number
    K042881
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phoenix Medical Devices, LLC
    Date Received
    October 19, 2004
    Decision Date
    November 18, 2004
    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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