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

    ELECTRIC MOBILITY RASCAL

    K Number: K924515 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    7
    Review Days
    570

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    Basic Information

    Device Name
    ELECTRIC MOBILITY RASCAL
    K Number
    K924515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Electric Mobility, LLC
    Date Received
    September 4, 1992
    Decision Date
    March 28, 1994
    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 Electric Mobility, LLC

    K Number Device Name
    K092130 RASCAL WE GO 250 POWERED WHEELCHAIR
    K002616 ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
    K991281 ELECTRIC MOBILITY CAVALIER SCOOTERS
    K972370 RASCAL POWER CHAIR
    K882669 APPOLLO BATH
    K874739 ELECTRIC MOBILITY'S SPARKY