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510(k) Data Aggregation

    K Number
    K031728
    Device Name
    KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
    Manufacturer
    KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH
    Date Cleared
    2004-10-12

    (496 days)

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

    KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. The device has heating capability, not cooling.
    Device Description
    This device is an external thermal regulating system consisting of blankets that are placed in contact with the patient, and a temperature controller and is to warming the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF). The function of the device is heating, not cooling. The heating element and sensor are both embedded inside the blankets. Four blanket sizes are available: 11- 100 Watts, Pediatric: 1.0 by 0.65 meters (3.3 by 2.17) and 3mm high (0.12 inches) weighing 0.9 kgs (Product code WD-01-100); 2 140 Watts, Adult: 2.0 by 1.35 meters (6.6 by 4.5 ft) and 3mm high (0.12 inches) weighing 2.0 kgs (Product code WD-01-200); 3- 40 Watts, Arm Shoulder: 1.5 meters (5.0 ft) and 3mm high (0.12 inches) weighing 1.0 kg (Product code 150-AW); 4- 50 Watts, Leg Warmer: 0.95 meters (3.17 ft) and 3mm high (0.12 inches) weighing 1.2 kgs (Product code 100-DB).
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    K Number
    K011859
    Device Name
    KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
    Manufacturer
    KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH
    Date Cleared
    2002-05-01

    (321 days)

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

    KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS INDICATED TO MAINTAIN PRESET BODY TEMPERATURE AS DETERMINED By THE PHYSICIAN. IT CAN ALSO BE UTILIZED TO MAINTAIN NORMAL BODY TEMPERATURE DURING SURCICAL PROCEDURES . IT IS INDICATED FOR USE IN HOSPITAL INVASIVE AND CORONARY CARD UNITS, IN OPERATING, RECOVERY AND EMERGENCY IN BURN UNITS, Rock's AND ON MEDICAL | SURGICAL floors
    Device Description
    This device is an external thermal regulating system consisting of a mat that is placed in contact with the patient and a temperature controller and is to regulate the patient's temperature between 30 and 37.7 ℃ (86 and 100ºF), using carbon technology. The heating element and sensor are both embedded inside the mat. Two mat sizes are available: 1- 95 Watts, Standard 0.950 by 0.495 meters (3.1 by 1.6 ft) and 9mm high (0.35 inches) weighing 5 kg (11 lbs) (Product code 75/95/12M) for adult patients 2- 55 Watts, Pediatric 0.550 by 0.495 meters (1.8 by 1.6 ft) and 9mm high (0.35 inches) weighing 3.5 kg (7.7 lbs) (Product code 55/95/12M) for pediatric patients 75/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 75/95/12M 55/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 55/95/12M
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