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510(k) Data Aggregation

    K Number
    K972486
    Device Name
    PRESSUREGUARD IV
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-02-20

    (233 days)

    Product Code
    IKZ
    Regulation Number
    890.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.
    Device Description
    The PressureGuard Turn Select is an air flotation, alternating pressure support system. It consists of a foam shell manufactured with medical grade, polyurethane foam that meets the California Technical Bulletin 117. The perimeter bolsters are designed to safely prompt the patient toward the center of the surface, facilitating safe transfers and edge-of-bed sittings. The inflation system is cradled and securely positioned within the foam shell. Through computerized technology, the internal air pressures of the inflation system are controlled to achieve four operating modes. The CENTER Mode provides a level supine surface. The FIXED ROLL Mode provides automatic turning, turning the patient to the left followed by a 2 hour dwell time, then returning to center for a 2 hour dwell time, followed by a turn to the right followed by a 2 hour dwell time. The CUSTOM ROLL Mode provides for selection of roll patterns, roll angles and dwell times to meet individual patient needs. The CPR Mode provides a firm surface to aid in CPR Procedures (with a crash board). A Service Required Feature is provided to alert the health care provider in the event of system malfunction. CPR Alarm and Lock-Out features are also included.
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    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?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    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
    K960188
    Device Name
    PRESSUREGUARD: SELECTCARE
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-10-02

    (260 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the prevention and treatment of pressure ulcers.
    Device Description
    The PressureGuard SelectCare is a powered air flotation mattress which provides pressure-reducing support within a range of adjustable firmness to meet individual comfort needs. The system also includes a CPR mode, providing a firm surface for performing CPR.
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    K Number
    K961502
    Device Name
    LUBRICATING JELLY, LOW VISCOSITY
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-07-18

    (90 days)

    Product Code
    KMJ
    Regulation Number
    880.6375
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
    Device Description
    Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
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    K Number
    K961159
    Device Name
    POWERED LOW AIR LOSS MATTRESS SYSTEM
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-06-14

    (84 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.
    Device Description
    The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air sacks as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.
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    K Number
    K960620
    Device Name
    PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-04-25

    (72 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the prevention and treatment of pressure ulcers.
    Device Description
    The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air cylinders as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.
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    K Number
    K960189
    Device Name
    GEL-T CUSHION
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-02-07

    (22 days)

    Product Code
    KIC
    Regulation Number
    890.3175
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954766
    Device Name
    PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-01-11

    (86 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPAN-AMERICA MEDICAL SYSTEMS, INC.

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

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