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510(k) Data Aggregation

    K Number
    K211919
    Device Name
    KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
    Date Cleared
    2022-03-04

    (256 days)

    Product Code
    Regulation Number
    890.3920
    Why did this record match?
    Product Code :

    KNN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KISS Dynamic Solid Drop Seat and Back Support devices are wheelchair components intended for medical purposes that are generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part. The KISS Dynamic Solid Drop Seat and Back Support are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seating platform or back support with dynamic motion.
    Device Description
    The KISS devices are wheelchair components intended for medical purposes generally sold as an integral part of a wheelchair but may also be sold separately as a replacement seat and back support. The KISS devices are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seat and back support with dynamic motion. The KISS Seat consists of (1) a solid seating platform, (2) an adjustable seat frame, (3) pivot blocks, and (4) springs. The KISS seat replaces the standard cloth seat on a wheelchair frame. It attaches to the wheelchair with (5) four drop hooks and is locked in place with (6) securing hardware. The KISS Back Support consists of (1) a lumbar support with (2) mounting brackets and (3) an upper back support with a solid ventilated (4) backrest. The lumbar support and the upper back support are hinged together with (5) springs therebetween. (6) Mounting hardware connects the KISS back support to the wheelchair frame in place of the standard cloth backrest. (7) A removable upholstered cover encases the back support assembly.
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