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

    MODEL 804 (TENS)

    K Number: K853442 · Decision Dec 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    6
    Review Days
    115

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    Basic Information

    Device Name
    MODEL 804 (TENS)
    K Number
    K853442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Oriental Medical Supplies, Inc.
    Date Received
    August 16, 1985
    Decision Date
    December 9, 1985
    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 Oriental Medical Supplies, Inc.

    K Number Device Name
    K893372 LATEX EXAMINATION GLOVES
    K871666 MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
    K853416 MES-TENS(TENS)
    K852610 HOT PACK
    K850566 MARUKYR-BAN / HOT OR HEAT PACK