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

    COACH 777-4

    K Number: K030757 · Decision Oct 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    7
    Review Days
    209

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    Basic Information

    Device Name
    COACH 777-4
    K Number
    K030757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wheelchair & Scooter Express
    Date Received
    March 11, 2003
    Decision Date
    October 6, 2003
    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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    Other Clearances by Wheelchair & Scooter Express

    K Number Device Name
    K030756 COACH 777-3
    K032441 F-10 FOLDING POWER CHAIR
    K032440 F-11 FOLDING POWER CHAIR
    K030758 COACH 888
    K030760 COACH 888W
    K030759 LITTLE COACH