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

    Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)

    K Number: K233092 · Decision Feb 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    4
    Review Days
    139

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
    K Number
    K233092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chongqing Rob Linka Science and Technology Co., Ltd.
    Date Received
    September 26, 2023
    Decision Date
    February 12, 2024
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.

    TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS/EMS device (GUSE01)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

    FDA 510(k)
    FDA Class 2 ·Neurology

    VEINOPLUS Back

    FDA 510(k)
    FDA Class 2 ·Neurology

    Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Chongqing Rob Linka Science and Technology Co., Ltd.

    K Number Device Name
    K233067 Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
    K233070 Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
    K230829 TENS7000 Rechargeable (Model:TENS7000 Rechargeable)