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

    EMS 400

    K Number: K022493 · Decision Oct 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    543
    Applicant Total
    7
    Review Days
    74

    Basic Information

    Device Name
    EMS 400
    K Number
    K022493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BODY CLOCK HEALTH CARE LTD
    Date Received
    July 29, 2002
    Decision Date
    October 11, 2002
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by BODY CLOCK HEALTH CARE LTD

    K Number Device Name
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    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
    K022076 FIRST CHOICE & FIRST CHOICE PLUS