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

    C.T.M. MOBITIY SCOOTER MODEL #HS-360

    K Number: K012792 · Decision Oct 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    7
    Review Days
    65

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    Basic Information

    Device Name
    C.T.M. MOBITIY SCOOTER MODEL #HS-360
    K Number
    K012792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Warepalmy Enterprise, LLC (Usa)
    Date Received
    August 20, 2001
    Decision Date
    October 24, 2001
    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 Warepalmy Enterprise, LLC (Usa)

    K Number Device Name
    K012791 C.T.M. MOBILITY SCOOTER MODEL # HS-320
    K002983 C.T.M. POWER CHAIR, MODEL HS-5600
    K000354 C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
    K000356 C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
    K983663 C.T.M. MOBILITY SCOOTER, MODEL # HS-666
    K983662 C.T.M. MOBILITY SCOOTER, MODEL # HS-686