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

    Wireless Pain Relieve Device

    K Number: K180331 · Decision Jun 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    25
    Review Days
    136

    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
    Wireless Pain Relieve Device
    K Number
    K180331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    February 6, 2018
    Decision Date
    June 22, 2018
    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 Shenzhen Dongdixin Technology Co., Ltd.

    K Number Device Name
    K240358 ShockPhysio Mobile (model SW3200 Basic)
    K213043 Levator Elite (Model LE9011)
    K210364 Migraine Tens Digital Pain Reliever
    K171430 Incontinence Treatment Device, Model LT2061
    K173462 Wireless Pain Relieve Device Model: LT5018C
    K171978 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
    K162479 Smart Pain Reliever, Model LT5019
    K161735 Non-contact Forehead Thermometer
    K150436 ComboRehab
    K142976 UltraTENS
    Search all 25 clearances from Shenzhen Dongdixin Technology Co., Ltd. →