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

    TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)

    K Number: K220152 · Decision Apr 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
    K Number
    K220152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hong Qiangxing (Shenzhen) Electronics Limited
    Date Received
    January 19, 2022
    Decision Date
    April 19, 2022
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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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)
    K220150 TENS & PMS (Model: SM9126)
    K201354 TENS & PMS
    K190009 Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
    K183154 SM Electrodes
    K133108 FIT BELT
    K121719 SM TENS & PMS