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

    PACESAVER & SCOUT

    K Number: K834506 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    7
    Review Days
    40

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PACESAVER & SCOUT
    K Number
    K834506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Burke, Inc.
    Date Received
    December 21, 1983
    Decision Date
    January 30, 1984
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.

    Virgo Mobility Scooter (Virgo-D,Virgo-F)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Scooter (YD-03)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (Air Carbon)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Mobility Scooter (X-12, X-14, X-17)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Electrical Scooter (SM4226)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Power Mobility Scooter (MJMA01, MJMA02)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Burke, Inc.

    K Number Device Name
    K061912 FUSION
    K023961 SCOUT BOSS
    K982158 SCOUT
    K965123 PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
    K911943 CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
    K893706 COLD/HOT FLUID RADIATION PAD NEUTECH