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510(k) Data Aggregation

    K Number
    K953796
    Device Name
    BANKS HYDRO-THERAPY CHAIR
    Date Cleared
    1996-04-01

    (231 days)

    Product Code
    Regulation Number
    890.5100
    Why did this record match?
    Product Code :

    ILM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.
    Device Description
    The Banks Hydro-Therapy Chair provides whirlpool therapy in the home so that patients do not require unnecessary hospitalization or require transportation to a hospital. The Banks Hydro-Chair comprises: a chair for supporting the patient, the chair may comprise a backrest, armrest, seat and frame; a hydro-pad, suction cups for removably fastening the chair to a bath tub, the lateral stability of the chair may be increased by a Stable Bar that is removably fastened to the backrest and a corresponding side wall of the bath in which the whirlpool therapy is taking place. The Hydropad is connected at the base of the Chair and the posterior opening of the Hydro-pad connects to a hose(typically rubberized tubing)) which is connected to a blower motor which exerts a powerful pressure of air circulating through the ports of the Hydro-pad. Streams of water jet through the ports causing a swirling motion of the water in which the Hydro-pad is immersed. The Chair is also composed of a seat portion and the Chair is open so jets of water can reach the sacral, coccyx, rectum, groin and vaginal areas of the patient utilizing the Hydro-Therapy Chair. The seating and backing of the Chair are made of soft polyethylene material to prevent undue pressure to the skin during therapy. For handicapped and disabled persons, the arm frames of the Chair are easily removable.
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