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

    COACH 888W

    K Number: K030760 · Decision Jul 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    7
    Review Days
    121

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    Basic Information

    Device Name
    COACH 888W
    K Number
    K030760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wheelchair & Scooter Express
    Date Received
    March 11, 2003
    Decision Date
    July 10, 2003
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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    Other Clearances by Wheelchair & Scooter Express

    K Number Device Name
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    K030758 COACH 888
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