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510(k) Data Aggregation

    K Number
    K172962
    Device Name
    Nurture Rest
    Date Cleared
    2018-01-18

    (114 days)

    Product Code
    Regulation Number
    880.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neonatal Loving Kare, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nurture Rest (including models 100-1-C) is indicated for premature infants undergoing oxygen therapy to maintain an airway and for whom treatment may be facilitated by this repositioning and stabilization device. The premature infants are being continuously monitored for oxygen saturation levels and heart rate in the Neonatal Intensive Care Unit (NICU) by medical professionals.
    Device Description
    Nurture Rest is an infant sleep positioning device used by medical staff to position and secure premature infants in a prone, supine, or side position to limit mobility within an incubator in the neonatal intensive care unit (NICU). The Nurture Rest is shaped like the female anatomy in order to encourage a "Kangaroo Care" style positioning technique that mimics being held against a female body/chest while also keeping the infant's head, neck, and spine aligned. This device gives nurses a useful tool in their daily role of repositioning and caring for these special premature infants. The infants for whom the device is used are undergoing oxygen therapy to maintain an airway (intubation, nasal CPAP, bubble CPAP, high flow nasal cannula, or nasal cannula) and are continuously monitored for oxygen saturation levels and heart rate. The Nurture Rest consists of a washable, flame-retardant cloth material. There are two models of the device (Models 100-1-O and 100-2-C). Both devices are appropriate for prone, supine and side positioning of premature infants. One model of the device (Model 100-1-O) has customizable opening at the head to allow for prone face-down positioning of micro-preemies for whom positioning with the head turned to the side would increase the chance of hemorrhaging due to increased intracranial pressure. The other model (Model 100-2-C) does not have an opening and is for prone with head turned positioning. The device comes with pillows to help stabilize the infant and swaddling straps to minimize motion of the arms and body of the infant. As with standard NICU practices, the Nurture Rest enables the infant to be re-positioned and treated as needed (typically every 4 to 6 hours), which allows NICU staff to cluster care in order to let the infants rest and grow in between physical and emotional stimulation.
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