BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PAINSHIELD MD

    K Number: K081075 · Decision Aug 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    PAINSHIELD MD
    K Number
    K081075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano Vibronix , Ltd.
    Date Received
    April 16, 2008
    Decision Date
    August 22, 2008
    Product Code
    PFW
    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
    PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

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