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

    1600 LIGHT TOUCH CONTROL

    K Number: K885103 · Decision Dec 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    10
    Review Days
    15

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    Basic Information

    Device Name
    1600 LIGHT TOUCH CONTROL
    K Number
    K885103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Rolcontrol Products, Co., Inc.
    Date Received
    December 12, 1988
    Decision Date
    December 27, 1988
    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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