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

    GEL FLOTATION MATTRESS

    K Number: K813226 · Decision Dec 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    7
    Applicant Total
    4
    Review Days
    22

    Basic Information

    Device Name
    GEL FLOTATION MATTRESS
    K Number
    K813226
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5150
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    JEFFERSON INDUSTRIES, INC.
    Date Received
    November 10, 1981
    Decision Date
    December 2, 1981
    Product Code
    IKY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IKY Mattress, Flotation Therapy, Non-Powered

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