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510(k) Data Aggregation

    K Number
    K964926
    Device Name
    BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
    Manufacturer
    JOERNS HEALTHCARE, INC.
    Date Cleared
    1997-11-03

    (329 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOERNS HEALTHCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To relieve pain and itching and as an aid in the healing of inflamed and traumatized tissue and as a setting for removal of contaminated tissue.
    Device Description
    The Parker Bath System consists of a fiberglass base unit and a movable fiberglass tub unit. The base unit contains the air spa blower unit and the battery pack, charger, and electro-hydraulic unit for moving the tub on models with electro-hydraulic powered movement. The tub unit contains the thermostatically controlled water mixing valve, shower hose, soap dispenser and air jet system. Some of the Parker Bath System models allow the tub to be moved vertically for ease of entry/exit of the patient and for ease of access for the caregiver. The vertical movement is powered either by a manual hydraulic pump or a 24 VDC battery powered electro-hydraulic pump unit. The tub units can all be tilted from an upright position for entry/exit/podiatry therapy to a fully reclined position for full body bathing/therapy. The tilting is powered either by a manual hydraulic pump or a 24 VDC battery powered electro-hydraulic pump unit. The patient enters the tub though a pivoting side door and sits on a molded in seat while the tub is in the upright position. The footwell of the tub can be prefilled with warm water through the thermostatically controlled mixing valve prior to the patient entering the tub. After the door is closed and latched, the air spa blower can be turned on for podiatry and lower leg hydromassage therapy, or the tub can be reclined, allowing the water to flow up and around the patient at which point bathing can be done using the integral shower hose or the air spa blower can be turned on for a full body hydromassage. After the bath the tub is tilted to the upright position, the water flows back to the footwell and the patient can be dried off and clothed while the water flows out the drain in the footwell.
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