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510(k) Data Aggregation

    K Number
    K093368
    Device Name
    BUTTERFLY TONER MODEL GYM070
    Date Cleared
    2010-01-27

    (90 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL MARKETING PARTNERS DBA GYMMAX USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Butterfly Toner is indicated for the improvement of abdominal muscle tone, strengthening of the abdominal muscles, and development of a firmer abdomen.
    Device Description
    The Butterfly Toner is a single channel, battery operated muscle stimulation system for exercising the abdominal muscles. The Butterfly Toner has two electrodes fixed at a distance of 28 mm.
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