BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WHEELCHAIR CUSHIONS

    K Number: K851814 · Decision Jul 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    28
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    WHEELCHAIR CUSHIONS
    K Number
    K851814
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3175
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Dignicare
    Date Received
    April 26, 1985
    Decision Date
    July 9, 1985
    Product Code
    KIC
    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
    KIC Cushion, Flotation

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