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510(k) Data Aggregation

    K Number
    K133980
    Device Name
    PANTHEON ELECTROSTIMULATOR
    Manufacturer
    PANTHEON RESEARCH
    Date Cleared
    2014-11-07

    (315 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANTHEON RESEARCH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pantheon Research Electrostimulator 4c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The Pantheon Research Pro Series electro-acupuncture stimulators are electrical stimulators that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients for therapeutic purposes. These devices are built in 5 models: the 4c.Pro. 6c.Pro. 12c.Pro. and 9c3i models. The Pantheon electro-acupuncture stimulator series does not come equipped with acupuncture needles. The practitioners should select 510(k) cleared needles
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