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510(k) Data Aggregation

    K Number
    K110994
    Device Name
    PARKER 500
    Manufacturer
    ARJOHUNTLEIGH INC
    Date Cleared
    2011-07-06

    (89 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
    Device Description
    The bathing system consists of a tub composed of fiberglass, which is covered by a panel containing all the integrated technical controls of the system. The bathing system is offered with or without a tub height positioning system, tub tilt system, hydro massage and an integrated disinfection system. The bathing system is not a sterile device.
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    K Number
    K082951
    Device Name
    IMMERSION HYDROBATH
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Date Cleared
    2009-04-08

    (187 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue
    Device Description
    Not Found
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    K Number
    K052479
    Device Name
    MBATH 1000 (60)
    Manufacturer
    ENNEKING MEDICAL INC.
    Date Cleared
    2006-01-26

    (139 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EMI mBath and eBath is a Product that consists of water agitators and a tub that is used in the bathing of an individual, by an attendee, in either a commercial or residential setting.
    Device Description
    The eBath uses a microprocessor to control water filling and emptying, while the mBath uses manual gages. The eBath offers temperature monitoring, with an integrated AC powered hydraulic lift and transport chair in which an attendant can use to assist an individual. The Product is available in both 60" and 70" lengths along with an optional door and weight scale.
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    K Number
    K040772
    Device Name
    PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM
    Manufacturer
    PENNER MANUFACTURING, INC.
    Date Cleared
    2004-04-05

    (10 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.
    Device Description
    Pacific Recumbent Height Adjustable Bath
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    K Number
    K012057
    Device Name
    CASCADE BATH, MODEL 6900
    Manufacturer
    PENNER MANUFACTURING, INC.
    Date Cleared
    2001-07-19

    (17 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.
    Device Description
    Not Found
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    K Number
    K012061
    Device Name
    SUPERIOR BATH, MODEL 6300
    Manufacturer
    PENNER MANUFACTURING, INC.
    Date Cleared
    2001-07-19

    (17 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.
    Device Description
    Superior Bath Model 6300
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    K Number
    K001079
    Device Name
    RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
    Manufacturer
    ARJO, INC.
    Date Cleared
    2000-05-01

    (27 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993872
    Device Name
    VANNA BATHING SYSTEM
    Manufacturer
    VANCARE, INC.
    Date Cleared
    2000-02-16

    (93 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.
    Device Description
    The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise.
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    K Number
    K992779
    Device Name
    A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
    Manufacturer
    MEDI-MAN REHABILITATION PRODUCTS, INC.
    Date Cleared
    2000-01-13

    (148 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bath for the bathing of disabled persons.
    Device Description
    Not Found
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    K Number
    K991184
    Device Name
    HYDROTONE-THERMAL CAPSULE SYSTEM
    Manufacturer
    NATS CORP.
    Date Cleared
    1999-06-23

    (76 days)

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

    ILJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrotherapy; Relieve pain and itching.
    Device Description
    Hydrotone-Thermal Capsule System
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