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510(k) Data Aggregation

    K Number
    K100585
    Device Name
    MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Date Cleared
    2011-01-20

    (324 days)

    Product Code
    DWJ, MED
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAYMAR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable. Indications for use for the Medi-Therm thermal regulating system include: a. To maintain pre-set body temperature as determined by the physician b. To maintain normal body temperature during surgical procedures c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors d. This system can be used with adult and pediatric patients e. Monitoring and controlling patient temperature f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
    Device Description
    The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.
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    K Number
    K073675
    Device Name
    T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Date Cleared
    2008-05-08

    (132 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAYMAR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable. Localized temperature therapy is of particular benefit in treating the following; orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, burns and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration: and symptoms such as infection and localized pain.
    Device Description
    The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that supplies warm or cold water at controlled temperatures to a water circulating pad for the application of localized temperature therapy. The control unit is an cloctrical device that uses a heating element to increase the temperature of water to controlled temperature set points, which the user selects from the digital display face. The temperature is controlled by a dual microprocessor control circuit and a thermostat to prevent overheating. To utilize the cold therapy option, the user adds ice water to the device, which will heat the water to a set point of 50 degrees Fahrenheit. The temperature range of the device ranges from 50 degrees Fahrenheit (for the cooling option) to 107 degrees Fahrenheit (the highest heating set point). The T-Pump Localized Temperature Therapy Purnp attaches to a connector hose that connects to the water-circulating pad; the temperature-controlled water flows from the pump to the pad. The pads are applied to the part of the body requiring temperature therapy, thereby providing the interface for the therapy. The T-Pump Localized Temperature Therapy Pump measures, in inches, 11.5 x 8 x 8. The device weighs under 10 pounds with the unit filled with water reservoir has a maximum capacity of 2750ml. The housing is composed of ABS Plastic and Polycarbonate. The leakage current is 100 microamperes maximum, and the flow rate is 9 gph (34 lph) minimum, with the water circulating pad attached.
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    K Number
    K962788
    Device Name
    CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Date Cleared
    1997-04-30

    (287 days)

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

    GAYMAR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.
    Device Description
    The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.
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    K Number
    K963067
    Device Name
    SOF. PRESS EPC 51 SYSTEM
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Date Cleared
    1997-01-28

    (174 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    GAYMAR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aid in the reduction and management of peripheral edema such as lymphedema and ulceration associated with vascular insufficiency.
    Device Description
    The Sof.Press EPC 51 System is an external pneumatic compression device that consists of a pump, an inflatable three cell sleeve, and connection tubing. Each cell of the sleeve is inflated sequentially with the highest pressure applied distally and with successively lesser pressures applied proximally.
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    K Number
    K961854
    Device Name
    SPR PLUS II OVERLAY SYSTEM (CL250/CL212
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Date Cleared
    1996-08-09

    (87 days)

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

    GAYMAR INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPR+II overlay system is a pressure relieving support system intended to reduce the potential for development of pressure ulcers on at risk patients or to be used in the treatment of existing pressure ulcers.
    Device Description
    The SPR+II System consists of an electromechanical inflation pump control unit which is connected to an overlay through a hose assembly connected to the inflation pump.
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