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510(k) Data Aggregation

    K Number
    K973169
    Device Name
    PRESSURE GUARD SITE SELECT (A)
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-02-20

    (179 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the prevention and treatment of pressure ulcers.
    Device Description
    The PressureGuard Site Select is an air flotation, alternating pressure support system which provides for customized selection of surface firmness for a head, upper torso, lower torso, and heel zones.
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    K Number
    K972022
    Device Name
    ZAK-2000
    Manufacturer
    CARDIO SYSTEMS, INC.
    Date Cleared
    1998-01-22

    (234 days)

    Product Code
    FNM, DAT
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR The PREVENTION AND TREAT M PRESSURE ULCERS OF
    Device Description
    Not Found
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    K Number
    K974319
    Device Name
    MIGHTY AIR
    Manufacturer
    WHEELCHAIRS OF KANSAS
    Date Cleared
    1998-01-22

    (66 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mighty*Air is used to help prevent and treat pressure ulcers.
    Device Description
    Not Found
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    K Number
    K974070
    Device Name
    PHYSIO/1000
    Manufacturer
    PHYSIO DESIGNS, INC.
    Date Cleared
    1998-01-06

    (70 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.
    Device Description
    Physio / 1000 Alternating Pressure Mattress System
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    K Number
    K972549
    Device Name
    SIMPULSE
    Manufacturer
    KINETIC CONCEPTS, INC.
    Date Cleared
    1997-11-18

    (133 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Simpulse mattress is for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. It employs a series of transverse inflatable cushions that can be sequentially inflated and deflated to provide pulsation pressures beneath the patient. The Simpulse is indicated for patients who would benefit from: A pressure relieving surface with the additional benefit of pulsation to assist in the prevention and treatment of the complications of immobility such as skin breakdown and decubitus ulcers.
    Device Description
    The Simpulse™ is a powered, Pulsating Therapy Mattress that can be used as an Overlay or Mattress Replacement System and is designed for use in all care settings (home, acute and extended). The Simpulse provides pulsating air suspension therapy that combines the benefits of pressure relief with the advantages of pulsation therapy. The Simpulse" is comprised of two major components: the Air Supply Unit, and the Mattress Assembly. The Mattress Assembly is comprised of: the pulsating air surface, the air base, the underliner and the cover sheet. The pulsating air surface is the component that pulses. It consists of ten separate interlocking air cushions that are plumbed to provide pulsation (five cushions are plumbed to Channel A and five are plumbed to Channel B). By only inflating the 5 inch pulsating air surface, the Simpulse " can be used as a mattress overlay. When the Simpulse is used as a Mattress Replacement System, the 3 inch air base is inflated and serves as a static pressure air base that keeps the patient suspended when the bed is articulated. It also serves as an air support and remains inflated in case of a power outage. The underliner serves as an envelope to provide structure to the mattress. It has tie points that snap together and hold the pulsating air surface in place in relation to the air base. It also has straps that secure the entire Mattress Assembly to the bed frame. The cover sheet is a fitted sheet made of nylon with a urethane backing that fits over the Mattress Assembly and provides a protective barrier between the patient and the air bladders. The Air Supply Unit is mountable on the footboard of a standard hospital bed or can be placed upright on the floor and is microprocessor controlled to achieve the two modes of operation (Pulsation and/or Static). All user input to the microprocessor control is accomplished through the membrane panel switch are located on the Air Supply Unit. The Air Supply Unit utilizes two separate pump and valve assemblies to channel compressed air to the Mattress Assembly, creating two sections referred to as Channel A and Channel B. This provides a single target pressure for the entire mattress as well as the means for the mattress to pulsate. The hose set has a connection on one end that mates to an air connection on the side of the Air Supply Unit. This connection also serves as a CPR emergency air deflation system by simply disconnecting the hose from the Air Supply Unit. The other end connects to the air cushions (Channel A, Channel B and the Air Base). The target pressure is set by pressing the "Soft/Firm" buttons located on the membrane control panel. These buttons have five LED's evenly spaced between them and the user can adjust the firmness of the mattress within the range of these five LED's. If the user pushes and holds one of the buttons, the LED location will not increment until the user releases the button and pushes it again. Once the user selects the pressure setting, the pressure feedback system will automatically maintain the pressure setting within a target pressure range of plus or minus 1" H2O. If the actual pressure moves out of the target pressure range, the microprocessor controller will activate the corresponding pump to increase the pressure or open the corresponding valve to decrease the pressure until the pressure is within the target pressure range. In the Static mode, all of the cushions in the air surface are inflated to an equal pressure and operate in a continuous pressure feedback mode as previously described. In the Pulsating On mode, the cushion closest to the footboard will decrease in pressure together with every other cushion along the mattresses length (Channel A), while the other set of cushions (Channel B) increase in pressure. Once the cushions of Channel A reach the lowest point and begin to increase in pressure, the cushions of Channel B start to decrease in pressure. When the Channel B cushions reach the minimum pressure and then begin to increase in pressure, the cushions of Channel A will once again begin to decrease in pressure. This completes a full cycle. By pressing the "Pulsation Cycle Time" button, the pulsation cycle time can be adjusted over a range of between 5, 10 or 20 minutes. An LED light will indicate which time period has been selected. The "Auto Firm" control will fill Channels A & B and the Air Base to a maximum inflation level. During the time that Auto Firm is activated, The Pulsation On/Off buttors, Pulsation Cycle Time Button and the Soft/Firm buttons as well as their respective LED indicators will be disabled. The mattress will stay at the maximum inflation level until the Auto Firm Off button is pushed or twenty minutes elapse from the time the Auto Firm On button was first pushed. The Simpulse will then default to the same settings of operation as before the AutoFirm was activated.
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    K Number
    K970081
    Device Name
    SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
    Manufacturer
    CATHAY CONSOLIDATED, INC.
    Date Cleared
    1997-11-07

    (302 days)

    Product Code
    FNM, ILA
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cathay Consolidated Super Air 9000 is indicated for the prevention and treatment of pressure ulcers ( bed sores).
    Device Description
    Super Air 9000 Alternating Air Flotation Mattress System
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    K Number
    K955243
    Device Name
    BARIAIR
    Manufacturer
    KINETIC CONCEPTS, INC.
    Date Cleared
    1997-10-23

    (708 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BariAir bed is indicated for patients weighing up to 850 pounds to aid in the prevention and treatment of complications of immobility. Particularly: - · patients who would benefit from a pressure relieving surface with the additional benefits of pulsation, percussion and/or continuous or regular turning from side to side. - · patients whose body weight and size pose a significant risk of injury to the patient or nursing staff during the performance of routine nursing care procedures.
    Device Description
    BariAir is a bariatric patient care system that combines the flexible patient-positioning capabilities of the predicato device (BariKare Plus) with a pressure relieving, dynamic low-air-loss mattress. The BariAir mattess is a three-section air mattress consisting of a scries of transverse, inflatable cushions that can be alternately inflated and deflated to provide pulsation therapy, four turning bladders to rotate the patient side to side, and an air bladder beneath the patient chest region cushions to provide vibration/percussion therapy. The BariAir device includes support and caster frames substantially the same as the predicate device. BariAir also provides continuous lateral rotation therapy, automatically turning the patient, as well as other adjunct therapies such as pulsation and vibration/percussion.
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    K Number
    K970468
    Device Name
    KT AIR BED
    Manufacturer
    KINETIC CONCEPTS, INC.
    Date Cleared
    1997-09-05

    (210 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KinAir IV and Therpulse II beds are for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. More particularly, it employs a patient supporting mattress overlay having an arrangement of transverse inflatable cushions that can be controlled to provide slowly pulsating pressures beneath the patient, as well as bladders to assist in turning the patient to one side or the other. The KinAir IV, Therapulse II Air Bed bed is indicated to assist in the prevention and treatment of the complications of immobility, especially for patients who would benefit from a pressure relieving surface with the additional optional benefit of pneumatic pulsation.
    Device Description
    The KinAir IV, Therapulse II (a.k.a. KT Air Bed) device is a pulsating low air-loss support mattress replacement system mounted on a commercially-available Stryker 3000 Acute Care Bed Frame, that also includes a Turn Assist feature. The mattress replacement system itself is essentially of the same general construction as the predicate Therapulse (510(k) No. K875321) and the KinAir (510(k) No. K880340 and the substantially equivalent TriaDyne device (510(k) No. K944094). It consists of the fabric support and the various cushions. The fabric support is a Gore-Tex fabric assembly for supporting and containing the twenty five upper cushions. Two additional inflatable cushions are on the underside of the fabric support, to assist the caregiver when turning the patient. All inflatable cushions are made of a vinyl Gore-Tex fabric to provide a low shear, low friction surface that is washable and durable. The KinAir IV, Therapulse II Air Bed has two general modes of operation: 1) static, and 2) turn assist, with an optional third mode, pulsation, available only on the Therapulse II. The Display membrane panel mounted on the footboard and in each foot siderail, are used to select the static and pulsing modes. For the static mode, four individually adjustable sections of upper cushions are inflated to support the patient with minimal air pressures. For the pulsing mode, over an adjustable cycle of between 2 1/2 and 40 minutes, some cushions are inflated and deflated more or less than others in order to alternate the pressures supporting the patient. The cycle repeats continuously until the pulse mode is deactivated. The Turn Assist mode is only available on the Home Display membrane panel mounted on the footboard. When the caregiver selects this mode to turn the patient either left or right, either the left or right bladder cushion will inflate and lean the patient approximately 15-20 degrees and stay inflated until the caregiver deactivates the turn assist mode. This feature was added to assist the caregiver when performing routine patient care, such as bathing, bedpan placement, etc. The blower unit and Air Supply Unit are mounted on the Stryker bed frame, beneath the mattress. They are controlled to achieve the various modes of operation according to user input through switches on the membrane panels mounted on the footboard and on the outside of the foot siderails. All user input is accomplished through these membrane panels. The membrane panels with the various settings and displays are illustrated throughout the KinAir IV and Therapulse II Quick Reference Guides. The Air Supply Unit's warmer is provided to warm air in the mattress for patient comfort. The blower is mechanically and electrically isolated to help prevent injury and reduce The warming element itself is a conventional resistive silicon heater. The warmer noise. actually warms the air in the Air Supply Unit's manifold, and the air then passively warms the patient to the degree selected by the patient's attendant. There are three settings: 1) LOW, 2) MEDIUM and 3) HIGH. At the HIGH setting, the heating element is capable of achieving maximum temperatures of roughly ten degrees Fahrenheit above ambient. Temperature feedback from sensors adjacent to the blower manifold allows for control of such temperatures. This is the same system that was used in the predicates Therapulse and KinAir. When first inflated, the KinAir IV and the Therapulse II are automatically set in the static mode. Pulsation therapy, available on the Therapulse II, only, when activated, begins alternating pressure between sets of cushions. When pulsation is first activated, the cushion closest to the footboard decreases its pressure, together with every other cushion along the mattress length, while the other pressures are increased. Once the first set of cushions reaches its lowest point and starts to increase, the second set of cushions starts to decrease. The second set reaches its minimum just as the first set reaches its maximum. The cycle then repeats all over again, resulting in a pulsating effect. The minimum cycle time of 2 1/2 minutes is the it takes for a pulsating cushion to partially deflate and then inflate again.
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    K Number
    K965207
    Device Name
    RID-DECUBE II
    Manufacturer
    SKIN CARE MANAGEMENT, INC.
    Date Cleared
    1997-08-21

    (237 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.
    Device Description
    The RID-decube II is an alternating pressure air flotation mattress intended for medical purposes with multiple air cells that can be filled and emptied in an alternating pattern by associated control units to provide regular, frequent and automatic changes in the distribution of body pressure.
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    K Number
    K972153
    Device Name
    ALTERNATING PRESSURE AIR FLOTATION MATTRESS
    Manufacturer
    DECUBITI CONCEPTS, INC.
    Date Cleared
    1997-07-31

    (52 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Product Code :

    FNM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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