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510(k) Data Aggregation

    K Number
    K180331
    Device Name
    Wireless Pain Relieve Device
    Date Cleared
    2018-06-22

    (136 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dongdixin Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
    Device Description
    The Wireless Pain Relieve Device includes TENS mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 23 pre-set TENS programs. In each program, the intensity can be adjusted. The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) or remote control. The communication is done via Bluetooth Low Energy. The APP operates on iOS or Android platforms (iOS 8.0 or greater, Android 5.0 or greater).
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    K Number
    K173462
    Device Name
    Wireless Pain Relieve Device Model: LT5018C
    Date Cleared
    2017-12-08

    (30 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Dongdixin Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    The Wireless Pain Relieve Device includes TENS, EMS (including MASSAGE Program) mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) and remote control. The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).
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