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510(k) Data Aggregation

    K Number
    K031045
    Device Name
    AEROLET TOILET LIFT, MODEL AER-01
    Date Cleared
    2003-07-10

    (71 days)

    Product Code
    Regulation Number
    890.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECONOMIC HOLLAND B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aerolet ToiletLift "K031045" was developed to assist in patient ability to access bathroom facilities due to medical conditions such as the following: Multiple Sclerosis Muscular Dystrophy Arthritis Inclusion Body Myositis Fredricks Ataxia Parkinsons Syndrome Post-Polio Syndrome Fragile elderly Rehabilitation Leg fractures Hip Replacement Knee Replacement Post-Operative Mobility
    Device Description
    The Aerolet Toilettift is an ergonomically correct aid to daily living tool that replicates the natural sitting and standing process needed for an individual to void. When standing. the end-user leans slightly back onto the raised Aerolet toilet seat, pushes the down button with either hand and waits for the unit to safely bring them over the bowl at a controlled speed. It is adjustable to accommodate any height toilet and can be custom fitted to an individual or multiple user's height. The Aerolet is also designed to allow the end user to stop on their way up or down allowing perineal cleaning. Afterwards, the end-user pushes the up button to rise to return to a full standing position enabling the user to walk away without assistance. Those desiring less assistance can either manually decrease the ifft at any point by letting off pressure to the up button. A switch can also be adjusted to decrease maximum lift height. The lift will stop at the preset limit and can not rise higher unless reset. An optional wired remote hand control is also available. One side note, the remote hand control overides the manual control built info the arm assembly. Other options include a variety of ergonomically correct seats from Pressalit. Soft seats are available in highly durable Gortex materials for durability. The electronic components are manufactured specifically for the Aerolet by LINAK, Durable Rislan powder coating profects the steels from deterioration from the harsh bathroom environment and corrosive bodily fluids. The mobile Aerolet is designed for the end user to take it with them when they travel or for use in institutional settings. The Bariatric version lifts consumers up to 880 pounds to enjoy the same benefits as that of the standard unit. This variation is accomplished by adding struts to the standard toiletlift. A larger seat adapts for larger users, The AEROLET Toiletifft is the standard product comprised of components. It can also be reconfigured with other components to be used as a Shower lift by removing certain electronics out of the product and attachina the unit to the shower wall for stability. All configurations of the AEROLET ToiletLift comply or exceed Manufacturer Guidelines for the United States of America and the European Union.
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