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510(k) Data Aggregation

    K Number
    K012804
    Device Name
    PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
    Manufacturer
    SCOTT E ALLEN CP
    Date Cleared
    2002-01-17

    (149 days)

    Product Code
    MVA
    Regulation Number
    882.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCOTT E ALLEN CP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use would include infants from three to eighteen months of age to be treated for Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This device is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.
    Device Description
    It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly.
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