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

    LIFESTYLE SOF. CARE GEL CHAIR CUSHION

    K Number: K882012 · Decision May 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    63
    Applicant Total
    27
    Review Days
    10

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    Basic Information

    Device Name
    LIFESTYLE SOF. CARE GEL CHAIR CUSHION
    K Number
    K882012
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3920
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Gaymar Industries, Inc.
    Date Received
    May 13, 1988
    Decision Date
    May 23, 1988
    Product Code
    KNN
    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
    KNN Components, Wheelchair

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