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510(k) Data Aggregation

    K Number
    K251958

    Validate with FDA (Live)

    Device Name
    VEINOPLUS Back
    Manufacturer
    Dynapulse Medical
    Date Cleared
    2025-12-23

    (181 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K130802
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Veinoplus® Back is to be used for temporary relief of pain associated with sore and aching muscles in the back (shoulder, middle of the back, or lumbar area), due to strain from exercise or normal household and work activities.

    Device Description

    VEINOPLUS Back is a non-invasive, battery-operated, over-the-counter device that provides transcutaneous electrical nerve stimulation (TENS). The VEINOPLUS Back consists of the handheld device with LCD screen and button controls, self-adhesive electrodes, cable to connect the device to the electrodes, 9V battery, and optional carrying accessories. When the device is in use, the on/off status, battery indicator, and stimulation intensity are displayed on the device's screen. The user is able to control the stimulation intensity via the button controls on the device and the device includes safety features such as automatic shut-off and patient override control.

    AI/ML Overview

    N/A

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