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

    C.T.M. POWER CHAIR, MODEL HS-2800

    K Number: K021617 · Decision Aug 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    14
    Review Days
    78

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    Basic Information

    Device Name
    C.T.M. POWER CHAIR, MODEL HS-2800
    K Number
    K021617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.T.M. Homecare Product, Inc.
    Date Received
    May 16, 2002
    Decision Date
    August 2, 2002
    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 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
    K090735 C.T.M. MOBILITY SCOOTER, HS-528
    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
    Search all 14 clearances from C.T.M. Homecare Product, Inc. →