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

    FIT BELT

    K Number: K133108 · Decision Aug 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    9
    Review Days
    309

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    Basic Information

    Device Name
    FIT BELT
    K Number
    K133108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hong Qiangxing (Shenzhen) Electronics Limited
    Date Received
    September 30, 2013
    Decision Date
    August 5, 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 Hong Qiangxing (Shenzhen) Electronics Limited

    K Number Device Name
    K253740 TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
    K220283 TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
    K220152 TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
    K220150 TENS & PMS (Model: SM9126)
    K201354 TENS & PMS
    K190009 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
    K183154 SM Electrodes
    K121719 SM TENS & PMS