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

    C.T.M. MOBILITY SCOOTER, HS-528

    K Number: K090735 · Decision Jul 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    14
    Review Days
    109

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    Basic Information

    Device Name
    C.T.M. MOBILITY SCOOTER, HS-528
    K Number
    K090735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.T.M. Homecare Product, Inc.
    Date Received
    March 19, 2009
    Decision Date
    July 6, 2009
    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 C.T.M. Homecare Product, Inc.

    K Number Device Name
    K110395 C.T.M. MOBILITY SCOOTER - MODEL HS 118
    K110567 C.T.M. MOBILITY SCOOTER HS515(3W)
    K091418 C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
    K073686 C.T.M. POWER CHAIR, MODEL HS-1500
    K070602 C.T.M. MOBILITY SCOOTER# HS-265
    K070603 C.T.M. MOBILITTY SCOOTER # HS-295
    K070025 C.T.M. MOBILITY SCOOTER, MODEL HS-310
    K040020 C.T.M. POWER CHAIR, MODEL HS-1000
    K032919 C.T.M. MOBILITY SCOOTER, MODEL HS-250
    K032918 C.T.M. MOBILITY SCOOTER, MODEL HS-235
    Search all 14 clearances from C.T.M. Homecare Product, Inc. →