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510(k) Data Aggregation

    K Number
    K172451
    Device Name
    Dr.MUSIC 3s
    Date Cleared
    2017-11-17

    (95 days)

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

    SmartMedicalDevice Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dr.MUSIC 3s (Model: DM-VME03S) is intended to be used by adults for temporary relief of pain associated with sore/ aching muscles in the shoulder, waist, upper extremities(arm) and lower extremities(leg) due to strain from exercise or normal household work activities and suitable for home use.
    Device Description
    Transcutaneous electrical nerve stimulation (TENS) is a non-invasive pain relief method. TENS treatment passes electrical pulses across the intact surface of the skin to activate the underlying nerves. The device uses a rechargeable battery to generate pulses. These pulses are applied onto the contact skin through self-adhesive reusable hydrogel electrodes. Dr.MUSIC 3s (Model: DM-VME03S) is an over-the-counter, home-use TENS device that consists of the following components: a main unit, which consists of the control unit and the battery unit; two electrodes; an electrode case; and a mobile app. The control unit contains the power/mode button and battery indicator, and is used to control the treatment mode and intensity level. The control unit connects to the battery unit via a Micro USB adaptor. The two re-usable adhesive hydrogel electrodes (which connect to the back of each the control unit and the battery unit using a snap button connector) deliver a low frequency pulse to the body by attaching on to the skin. The user can choose from three treatment output modes (music, tapping, or massaging) and various intensity levels. The treatment modes and intensities can be controlled via the control unit or via a mobile app. The app allows the user to control and display the output intensity of the stimulation, change the operation mode, and display the time of use, among other features. The mobile app can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The mobile devices must run on an operating system consisting of iOS 7.0 or later version: or Android 4.3 or later version. The mobile app and the unit communicate via Bluetooth technology. The device components are not supplied sterile and do not require sterilization or processing prior to use.
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