BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    FIRST CHOICE & FIRST CHOICE PLUS

    K Number: K022076 · Decision Sep 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    FIRST CHOICE & FIRST CHOICE PLUS
    K Number
    K022076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Body Clock Health Care, Ltd.
    Date Received
    June 26, 2002
    Decision Date
    September 24, 2002
    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 Body Clock Health Care, Ltd.

    K Number Device Name
    K091045 SMART TENS, MODEL: D-BC05T
    K041359 BODY CLOCK STIMPLUS AND STIMPLUS PRO
    K022849 BODY CLOCK TENS N' TONE
    K021846 804SIII; 804W; LIBRA TENS; 410; S-TENS II
    K022731 V TENS PLUS
    K022493 EMS 400