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510(k) Data Aggregation

    K Number
    K052182
    Device Name
    SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
    Manufacturer
    SHIAN JIA MEEI ENTERPRISE CO., LTD.
    Date Cleared
    2005-11-04

    (86 days)

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

    SHIAN JIA MEEI ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain.
    Device Description
    SHIAN JIA MEEI TWO Channel Digital T.E.N.S.( Transcuntaneus Electrical Nerve Stimulator), is of independent two channels output , designed for symptomatic relief and management of chronic intractable pain. It provides a combination of adjustable frequency , adjustable Pulse Width and adjustable output current intensity. With large LCD panel. It is powered by 9V Battery. SHIAN JIA MEEI TWO Channel Digital T.E.N.S. requires the use of two (2) set of lead-wire and two (2) pairs of cutaneous stimulation electrodes. Model No. description TKL-008/ TKL-168/ TKL-268 is all the same except the Housing printing artwork , model no. & destination.
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    K Number
    K040311
    Device Name
    SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
    Manufacturer
    SHIAN JIA MEEI ENTERPRISE CO., LTD.
    Date Cleared
    2004-10-01

    (235 days)

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

    SHIAN JIA MEEI ENTERPRISE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SHIAN JIA MEEI DIGITAL PWM TENS is intended for symptomatic relief and management of chronic intractable pain.
    Device Description
    The SHIAN JIA MEEI DIGITAL PWM TENS (Transcutaneous Electrical Nerve Stimulation) is designed for symptomatic relief and management of chronic intractable pain. The device has eight stimulating modes providing the different feeling of effects, with mode setting. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. SHIAN JIA MEEI DIGITAL PWM TENS requires the use of a set of lead-wire and one pair of cutaneous stimulation electrodes. Model No. description · YW-6000, UC-332 , UC-330 are identical in circuitry , LCD display , housing -etc. , except they are for different customers(destination). This means the three models ST-331 is identical to model YW-6000/UC-332 /UC-330 except the customers (destination) and the layout shown on the LCD display.
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