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510(k) Data Aggregation

    K Number
    K012007
    Device Name
    RHS HELMET
    Manufacturer
    RESTORATIVE HEALTH SVS, INC.
    Date Cleared
    2001-09-19

    (84 days)

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

    RESTORATIVE HEALTH SVS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RHS Helmet is a cranial orthosis that applies passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic- shaped heads.
    Device Description
    The RHS Helmet is a cranial orthosis that applies passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly. It consists of a polypropylene helmet, three-eighths of an inch thick, that is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for ventilation, and large holes for the child's ears.
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