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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL

    K Number: K130723 · Decision Feb 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    6
    Review Days
    326

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    Basic Information

    Device Name
    FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
    K Number
    K130723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Famidoc Technology Co., Ltd.
    Date Received
    March 18, 2013
    Decision Date
    February 7, 2014
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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    Other Clearances by Famidoc Technology Co., Ltd.

    K Number Device Name
    K212918 Heat StimPlus
    K113010 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
    K113761 INFRARED THERMOMETER
    K072641 DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
    K052849 INFRARED THERMOMETER, FDIR-V1