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

    RANGEROLLER (MODIFIED)

    K Number: K920325 · Decision Mar 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    550
    Applicant Total
    2
    Review Days
    51

    Basic Information

    Device Name
    RANGEROLLER (MODIFIED)
    K Number
    K920325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    EXCEL MOBILITY PRODUCTS, INC.
    Date Received
    January 15, 1992
    Decision Date
    March 6, 1992
    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 EXCEL MOBILITY PRODUCTS, INC.

    K Number Device Name
    K915152 RANGEROLLER