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510(k) Data Aggregation

    K Number
    K961809
    Device Name
    SHE-LI TENS STIMULATOR MODEL SL-101 RX
    Manufacturer
    MEDI CONSULTANTS, INC.
    Date Cleared
    1997-02-26

    (292 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The She-Li TENS (TM) device is indicated for reducing the symptoms of : Chronic Intractable Pain, and Post Traumatic Acute Pain by placing contacts on the body per instructions by Dr. C.N.Shealy,M.D.,Ph.D. for the type of pain encountered.
    Device Description
    The She-Li TENS(TM) utilizes the same solenoid coil and interrupter assembly which is at the heart of the Electreat device. Shrouded receptacles are utilized in the She-Li TENS(TM), as recommended by the Agency. Two Alkaline "C" cell batteries are used in a more up to date mechanical package. The Electrical output of the She-Li TENS (TM) is identical to that of the former Electreat. However, the She-Li TENS(TM) provides safer, shrouded output receptacles for the single channel (just as in the original Electreat device) .
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