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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?
    Product Code :

    FQM

    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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    K Number
    K040054
    Device Name
    BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
    Manufacturer
    THEODORE BARASH
    Date Cleared
    2004-04-27

    (106 days)

    Product Code
    FQM
    Regulation Number
    880.5075
    Why did this record match?
    Product Code :

    FQM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.
    Device Description
    (a) Elasticized fitment to support and compress an injured part of the body. (b) Anatomically contoured for adjustable fit and firmness for personal comfort and control of slippage and bunching of fabric. (c) Absortek fiber absorbs perspiration and transfers heat and moisture away from skin (d) Fabric treated with agent to resist growth of odor-causing bacteria and mildew (e) Non-intrusive magnetic panel encased in fabric.
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    K Number
    K013244
    Device Name
    COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
    Manufacturer
    MED GEN, INC.
    Date Cleared
    2001-12-07

    (70 days)

    Product Code
    FQM
    Regulation Number
    880.5075
    Why did this record match?
    Product Code :

    FQM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComfortCare Compression Support with Magnets & Anti-Bacterial Agent is designed to provide relief of minor physical discomforts that have their origin in strenuous or intense physical activities associated with athletic, workplace and at-home activities. Device provides support for relief of minor physical discomforts and at-home activities. Device provides support for relief of discomfort in self-limiting physical injuries. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in compressed areas, minimizing potential for skin irritation. ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.
    Device Description
    (a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew
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