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

    MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR

    K Number: K871666 · Decision Jun 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
    K Number
    K871666
    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
    April 28, 1987
    Decision Date
    June 25, 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 Oriental Medical Supplies, Inc.

    K Number Device Name
    K893372 LATEX EXAMINATION GLOVES
    K853442 MODEL 804 (TENS)
    K853416 MES-TENS(TENS)
    K852610 HOT PACK
    K850566 MARUKYR-BAN / HOT OR HEAT PACK