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510(k) Data Aggregation

    K Number
    K030669
    Device Name
    PROVIDENCE MOLDING HELMET
    Date Cleared
    2003-07-18

    (137 days)

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

    NORTHEAST ORTHOTICS AND PROTHETICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.
    Device Description
    The Providence Molding Helmet is a cranial orthosis used to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brachyecephalic-, and scaphocephalic- shaped heads. This device works by applying gentle holding pressure to the prominent regions of the infant's skull while leaving room for growth in the adjacent flattened regions. The Providence Molding Helmet consists of a 5/32 polypropylene outer shell and two (2) layers of 3/16 volara foam inner lining. The helmet is split posteriorly and an elastic Velcro strap is attached to the back of the helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape. The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.
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