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

    LASER 4SPSC340

    K Number: K003059 · Decision Mar 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    20
    Review Days
    150

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    Basic Information

    Device Name
    LASER 4SPSC340
    K Number
    K003059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pride Mobility Products Corp.
    Date Received
    October 2, 2000
    Decision Date
    March 1, 2001
    Product Code
    INI
    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
    INI Vehicle, Motorized 3-Wheeled

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