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510(k) Data Aggregation

    K Number
    K143414
    Device Name
    Hill-Rom Wireless Connectivity Module
    Manufacturer
    HILL-ROM
    Date Cleared
    2015-03-10

    (102 days)

    Product Code
    IOQ, FNL
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill- Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill- Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.
    Device Description
    The Hill-Rom Wireless Connectivity Module is a wireless module installed on specific Hill-Rom bed models. The Hill-Rom Wireless Connectivity Module is integrated into existing bed platforms via a USB connection to the bed's electrical system and provides connectivity to a remote server application. The Hill-Rom Wireless Connectivity Module is used to assist staff to monitor hospital bed status and to assist the healthcare provider in providing patient care. The optional feature is mounted onto Hill-Rom hospital beds to wirelessly transmit bed information such as: bed exit status, bed side rail status, bed brake status, head of bed angle, and patient weight from bed scale. The Hill-Rom Wireless Connectivity Module is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device which communicates with a remote server in the hospital. The bed status data may be displayed at user-defined locations, such as nursing stations. It may also be shared with EMR (Electronic Medical Record) Systems through integration with 3rd party systems.
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    K Number
    K122473
    Device Name
    TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
    Manufacturer
    HILL-ROM
    Date Cleared
    2013-06-03

    (293 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.
    Device Description
    The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.
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    K Number
    K973624
    Device Name
    NURSE'S AID PATIENT ROTATION SYSTEM
    Manufacturer
    AIR MED ASSIST PRODUCTS
    Date Cleared
    1998-01-21

    (120 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.
    Device Description
    An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.
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    K Number
    K970363
    Device Name
    HYDROTEC LOW AIR LOSS THERAPY BED
    Manufacturer
    APEX METAL, INC.
    Date Cleared
    1997-11-17

    (290 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apex Metal HydroTec™ is indicated for the prevention and treatment of pressure ulcers ( bed sores).
    Device Description
    Not Found
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    K Number
    K970364
    Device Name
    AIRTEC2 LOW AIR LOSS THERAPY BED
    Manufacturer
    APEX METAL, INC.
    Date Cleared
    1997-11-17

    (290 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apex Metal AirTec2 Low Air Loss Therapy Bed is indicated for pressure relief for patients with pressure sores, burns, amputations, shin flap or graft surgery, that may be in Neurology, Dermatology, Rehabilitation or Orthopedics. For pain management and pressure relief consider the AirTec2 for patients with arthritis, AIDS or cancer.
    Device Description
    AirTec2™ Low Air Loss Therapy Bed
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    K Number
    K970636
    Device Name
    TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
    Manufacturer
    HILL-ROM, INC.
    Date Cleared
    1997-08-26

    (187 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is a device intended for medical purposes that consists of a mattress and a control unit which provides automatic changes in distribution and control of interface pressure. It is used to prevent and treat conditions where reduction of interface pressure is beneficial. The device is intended to provide a patient surface suitable for use with the general patient population in a variety of health care environments as determined appropriate by health care professionals. The TotalCare.. Modular Therapy System (MTS) is intended to be used in conjunction with the TotalCare. Patient Support System (PSS). The MTS is not intended for use with patients with unstable cervical fractures.
    Device Description
    The TotalCare~ Modular Therapy System (MTS) is a patient Air Flotation Bed surface operated by a microprocessor controlled air system and proportional air valves. The mattress surface is of a modular design This allows the healthcare facility to add treatment and/or prevention opiions as the patient condition requires. The Surface Control Modules contain the software and proportional air valves and dock with the TotalCarem Patient Support System (PSS) Bed. The MTS surface maintains peripheral circulation by even distribution of the patient's weight over bladders filled with air. The even distribution of pressure on the skin reduces capillary closure, thereby helping maintain tissue viability around bony prominences, such as the buttocks and heels, both areas prone to ulceration and bed sores. The surface cover is non-permeable and will not allow the accumulation of perspiration and other bacteria producing body fluids within the cover or bladder of the bed. By wiping of the cover to remove any accumulation of fluids, followed by wiping of the surface of the cover with an antiseptic agent, contamination of the patient is reduced or eliminated.
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    K Number
    K964873
    Device Name
    SILKAIR LOW AIRLOSS THERAPY
    Manufacturer
    HILL-ROM, INC.
    Date Cleared
    1997-07-03

    (210 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.
    Device Description
    This product provides the therapeutic surface features and leg elevation bed features of the Flexicair® Low Airloss Therapy Unit while eliminating the hospital bed frame. The intent of the design of the SILKAIR™ Low Airloss Therapy is to provide a zoned low airloss surface with the capabilities of head and leg elevation for non articulating bed frames or mattress box springs. SILKAIR attaches the low airloss surface to a positioning base which provides the head and leg articulation features. This positioning base can be attached to any flat surface such as a box spring, converting a regular bed into a hospital bed. The SILKAIR™ Low Airloss Therapy System is a zoned low airloss surface. The system distributes different pressures in different zones relative to the main air manifold pressure. This system uses basic, simple mechanical and electrical components. Head and leg articulation required by many patients in the home is achieved through the use of a positioning base. This positioning base consists of plastic support plates and accordion bladders to raise and lower the head and leg sections of the surface.
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    K Number
    K970295
    Device Name
    FLEXICAIR EXLIPSE PLUS
    Manufacturer
    HILL-ROM, INC.
    Date Cleared
    1997-05-16

    (109 days)

    Product Code
    IOQ
    Regulation Number
    890.5170
    Why did this record match?
    Product Code :

    IOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The standard FLEXICAIR® ECLIPSE™ , the FLEXICAIR® ECLIPSE™ PLUS the FLEXICAIR® ECLIPSE™ ULTRA Mattress Replacements are intended to provide low-airloss therapy for different ranges of patient weights. The standard FLEXICAIR® ECLIPSE™ , used on general Med-Surg or specialty beds covers all patient weights up to 300 lbs. The FLEXICAIR® ECLIPSE™ PLUS covers patient weights from 301 lbs to 450 lbs on Hill-Rom Centra and Advance 1000 bed frames and on the Stryker MPS bed frame. The FLEXICAIR® ECLIPSE™ ULTRA covers patient weights from 451 to 800 lbs on the Hill-Rom Magnum/Magnum II bed frames. Air-fluidized and low airloss beds have been used for comfort and therapy for individuals who could not move themselves. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as be a valuable aid in the treatment of bed sores. Low airloss therapy maintains patient's peripheral circulation by distributing the patient's weight over cushions filled with air. The even distribution of pressure on the skin limits capillary closure, thereby helping maintain tissue viability around bony prominence such as the sacrum and heels. The numerous cushions in the FLEXICAIR® ECLIPSE™ help to decrease shear forces against the skin by moving independently of one another while the fabric helps to decrease friction. A non-permeable cover, or coverlet, placed over the cushions prevents the transmission of perspiration and body fluids to the cushions.
    Device Description
    The FLEXICAIR® ECLIPSE™ is a Portable Powered Flotation Therapy Mattress system. It consists of an air supply unit and mattresses. The air supply unit contains a blower, controller, and valves. The mattresses are composed of multiple air cushions attached to a substrate, with variations in height, number of cushions, and zoning depending on the specific model (Standard, PLUS, or ULTRA). The system utilizes proportional valves to control air pressure.
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