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

    PC 2909A-HEALTH PULSE CONTROL STIMULATOR

    K Number: K830747 · Decision May 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    PC 2909A-HEALTH PULSE CONTROL STIMULATOR
    K Number
    K830747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    J.A. Preston Corp.
    Date Received
    March 9, 1983
    Decision Date
    May 30, 1983
    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 J.A. Preston Corp.

    K Number Device Name
    K861739 TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR