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510(k) Data Aggregation

    K Number
    K040936
    Device Name
    PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
    Manufacturer
    LEDA CO., LTD.
    Date Cleared
    2004-05-03

    (24 days)

    Product Code
    FQM
    Regulation Number
    880.5075
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEDA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to provide relief of minor physicial discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
    Device Description
    The Petit Silma Elastic Bandage is a simple device to provide relief of minor physical discomforts arising from stress or strain of repetitive actions including athletic, workplace and at-home activities. It consists of an elastic compression bandage, containing the element Germanium in a circular pellet. The product is worn on the injured portion of the body (elbow, knee, wrist) as appropriate. Alternatively, a second version of the the product would contain a Titanium Oxide pellet, instead of Germanium.
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