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

    PARAGOLFER

    K Number: K060936 · Decision Aug 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    65
    Applicant Total
    1
    Review Days
    124

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    Basic Information

    Device Name
    PARAGOLFER
    K Number
    K060936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Parabasetec, GmbH
    Date Received
    April 5, 2006
    Decision Date
    August 7, 2006
    Product Code
    IPL
    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
    IPL Wheelchair, Standup

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