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510(k) Data Aggregation

    K Number
    K103362
    Device Name
    AOI CRANIAL HELMET
    Date Cleared
    2011-04-18

    (152 days)

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

    ADVANCED ORTHOPRO INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AOI Cranial Helmet is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads.
    Device Description
    The AOI Cranial Helmet is a cranial orthosis which is made through a custom fabrication process to apply mild pressure to prominent regions of a young child's cranium to slow further growth in that area while allowing flattened portions of the cranium to grow into voids built into the helmet in order to improve overall cranial symmetry. The helmet itself, once finished and delivered, covers the majority of the head and is trimmed as follows. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above the ears. The posterior inferior is trimmed low to capture the occiput. A Velcro strap is attached to one side of the helmet to keep it securely in place. The finished AOI Cranial Helmet is composed of a hard outer shell, made of thermoform-able plastic (Copolymer 5/32 inch) and an inner layer of polyethylene foam ( 1/2 inch).
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