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510(k) Data Aggregation

    K Number
    K170145
    Device Name
    Digital TENS Unit
    Date Cleared
    2017-04-29

    (102 days)

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

    SHENZHEN EAPPLY TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
    Device Description
    Digital TENS Unit is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (neck, shoulders, back, waists, arms, and legs). At the same time, the proposed TENS device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the Pad Lead Cords and Electrode Gel Pads to the uses' skin for pain relief. to the user's skin through the pad lead cords and electrode gel pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the Controller's interface of the device.
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