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

    TENS MODEL 240Z

    K Number: K920266 · Decision Dec 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    6
    Review Days
    317

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    Basic Information

    Device Name
    TENS MODEL 240Z
    K Number
    K920266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oms Medical Supplies, Inc.
    Date Received
    January 21, 1992
    Decision Date
    December 3, 1992
    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 Medical Supplies, Inc.

    K Number Device Name
    K963194 ITO ACUPUNCTURE NEEDLES
    K904388 POINTER F-3 TENS
    K904332 MSTIM-2000 EMS
    K894964 K-2 TENS OR MED TENS
    K884210 TX-7 (TENS) (IC-1107)