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

    TENS DEVICE FOR RELIEF OF CHRONIC PAIN

    K Number: K864114 · Decision Apr 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    17
    Review Days
    162

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    Basic Information

    Device Name
    TENS DEVICE FOR RELIEF OF CHRONIC PAIN
    K Number
    K864114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Futuremed Div. of Future Impex Corp.
    Date Received
    October 21, 1986
    Decision Date
    April 1, 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 Futuremed Div. of Future Impex Corp.

    K Number Device Name
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    K901308 SPIRO ANALYZER MODEL ST 250
    K884972 TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
    K871421 MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
    K873817 SPIRO ANALYZER ST-300
    K872044 CARBON ELECTRODE
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