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510(k) Data Aggregation

    K Number
    K151050
    Device Name
    Pacifier Activated Lullaby (PAL®)
    Manufacturer
    Power Medical Devices, LLC
    Date Cleared
    2015-12-22

    (246 days)

    Product Code
    HCC
    Regulation Number
    882.5050
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    Applicant Name (Manufacturer) :

    Power Medical Devices, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pacifier Activated Lullaby (PAL®) encourages and reinforces effective non-nutritive sucking of premature infants. This is accomplished by giving positive feedback to the infant in the form of music or a mother's voice as auditory input in direct response to sucking.
    Device Description
    The Pacifier Activated Lullaby ("PAL®") has a player module, pacifier sensor module and power supply. The pacifier sensor module senses the strength and duration of an infant's sucking on an attached pacifier and responds with music or a recorded sound (i.e. mother's voice) contingent to the infant's sucking. The pacifier module consists of a wired transmitter with a built in pressure transducer that connects to the pacifier and a receiver. The receiver decodes the signal and plays music or a recorded sound for a predetermined length of time via a speaker to the infant contingent on his/her sucking on the pacifier transmitter. This action occurs when the sucking strength and duration exceeds preset values. The user can control the sensitivity of the transducer. This application describes modifications to the FDA cleared K010388 P.A.L. System.
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