LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071866
    Device Name
    NTRAINER SYSTEM
    Manufacturer
    KCBIOMEDIX, INC.
    Date Cleared
    2008-02-01

    (210 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KCBIOMEDIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NTrainer System reinforces non-nutritive suck (NNS) in newborns and infants born prematurely.
    Device Description
    A Soothie™ pacifier is inflated by a low pressure air pump that stimulates the baby's lips, tongue and jaw thus allowing the NTrainer System to reinforce non-nutritive suck (NNS) in newborns and infants. This is accomplished by providing the newborns or infants with a synthetic patterned oral somatosensory input. The NTrainer consists of the motor assembly, air cylinder, control electronics and computer system including a display. The only interface and contact with the baby is the disposable Soothie Pacifier. TM The application software has two modes of operation, NeoSuck, the assessment mode which defines the baby's state of non-nutritive suck development and, NTrainer, the therapy mode which reinforce the development of non-nutritive suck.
    Ask a Question

    Page 1 of 1