BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TX-4(TENS) (SIGMA TENS)

    K Number: K874550 · Decision Nov 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    7
    Review Days
    16

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    Basic Information

    Device Name
    TX-4(TENS) (SIGMA TENS)
    K Number
    K874550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Oms Medico, Inc.
    Date Received
    November 4, 1987
    Decision Date
    November 20, 1987
    Product Code
    GZJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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    Other Clearances by Oms Medico, Inc.

    K Number Device Name
    K874333 TX-2(TENS)
    K873420 GLOBALCARE(TENS)
    K873484 120Z(TENS)
    K871699 TX-3(TENS)
    K865063 UNI-PULS(TENS) MODEL #292
    K870583 NEU-PULS(TENS) MODEL #295