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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    MED GEN, INC.

    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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    K Number
    K013239
    Device Name
    COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
    Manufacturer
    MED GEN, INC.
    Date Cleared
    2001-11-20

    (53 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED GEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries. ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation. ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.
    Device Description
    (a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.
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