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510(k) Data Aggregation

    K Number
    K140163
    Device Name
    KOALA TOCO
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Date Cleared
    2014-05-29

    (127 days)

    Product Code
    HFM, HFN
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting. The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring. The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.
    Device Description
    The Koala TOCO is a single-use tocodynamometer that is a transducer pressure-sensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each. The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO. The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.
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    K Number
    K061044
    Device Name
    FEATHERLITE AQUA TOCODYNAMOMETER
    Manufacturer
    VENTREX, INC.
    Date Cleared
    2006-07-12

    (89 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FeatherLite Aqua™Toco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite Aqua™Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients, It is held on the surface of the abdomen using a standard button hole or Velcro™ type belt. The product is supplied non-sterile and is intended for single use only.
    Device Description
    The FeatherLite Aqua™ tocodynamometer (toco) is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The fetal monitor is not intended for home monitoring or pre-term labor. It can be used in both dry and fully submerged environments It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single use only.
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    K Number
    K040392
    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    Manufacturer
    AMERICAN I.V. PRODUCTS, INC.
    Date Cleared
    2004-09-14

    (210 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient. AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate. AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions. AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.
    Device Description
    AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors. The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.
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    K Number
    K013477
    Device Name
    TOCO LITE, MODEL TD-01
    Manufacturer
    VENTREX, INC.
    Date Cleared
    2002-01-17

    (90 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FeatherLite Toco tocodynamometer is intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting. Caution: The FeatherLife Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients. It is held in place on the surface of the abdomen using the attached elastic belt.
    Device Description
    The FeatherLite Toco is generally rectangular in shape with a domed sensor body and nipple-like appendage. It includes a belt to hold it on the patient. The device is lower profile and significantly lighter than standard tocos. The rectangular base and dome sensor body are molded from thermoplastic. The sensing nipple is formed from a flexible polymer. The sensor is a strain gauge. The cable is a jacketed array of four individually insulated wires. The belt is an elastic nylon webbing.
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    K Number
    K994353
    Device Name
    SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
    Manufacturer
    PRECISION DYNAMICS CORP.
    Date Cleared
    2000-03-22

    (90 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby's heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple "button holes" for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing.
    Device Description
    The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one blue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.
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    K Number
    K992811
    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    Manufacturer
    EPIC MEDICAL EQUIPMENT SERVICES, INC.
    Date Cleared
    2000-01-18

    (151 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.
    Device Description
    Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.
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    K Number
    K954847
    Device Name
    DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
    Manufacturer
    OCG SYSTEMS, INC.
    Date Cleared
    1996-05-22

    (212 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Product Code :

    HFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.
    Device Description
    The Disco™ Uterine Contraction Transducer System is a non-sterile, single patient use external uterine contraction transducer and accessories. The system consists of a disposable belt with the transducer, an adapter cable with sensitivity switch for use with either Corometrics or Hewlett Packard patient monitor, and the package with appropriate label copy. The Disco™ Uterine Contraction Transducer System uses a transducer that is placed in contact with the maternal abdomen and the output signal is displayed on a monitor and/or recording device. The transducer is composed of a mylar sheet with a pressure sensitive ink silk screened to its surface. This ink responds to changes in pressure from the foam pad by changing its electrical resistance. A series of conductive silver traces silk screened to a rigid ceramic substrate allow termination and measurement of this changing electrical resistance. A firm, yet flexible rounded elastomeric button is used to transfer the uterine contraction from the patient to the transducer. It is mounted in the center of the transducer and has an achesive bond to the foam pad at its base. A thin, flexible, stranded, insulated wire is used to connect the transducer to the adapter cable. A two wire RJ-11 male telephone type connector is used as the electrical interface for the transducer. Because the pressure sensitive ink produces a stronger signal than strain gauge type transducers, the Disco™ Uterine Contraction Transducer System has an output control switch to adjust the level of the output signal.
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