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

    KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat

    K Number: K211919 · Decision Mar 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    256

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    Basic Information

    Device Name
    KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
    K Number
    K211919
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3920
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kinetic Innovative Seating System, LLC
    Date Received
    June 21, 2021
    Decision Date
    March 4, 2022
    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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