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510(k) Data Aggregation

    K Number
    K982096
    Device Name
    DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO
    Manufacturer
    RAPID MFG. CO.
    Date Cleared
    1999-06-18

    (368 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Abbreviated
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For USE WITH TEN.S and E.M.S DEVICES Only (This Product is not designed as a monitoring electrode and should not be used for that purpose..) Pre-gelled EleCTRODES TO BE UTILIZED WITH TEN'S OR EMS DEVICE

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, or device performance. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the "Dermastim Plus" and related devices to legally marketed predicate devices. It discusses regulatory classifications, general controls, and contact information for further inquiries.

    Therefore, I cannot extract the requested information to fill in the table or answer the specific questions regarding acceptance criteria and the study proving the device meets those criteria.

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