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510(k) Data Aggregation

    K Number
    K113321
    Device Name
    TENS BACK PAIN RELIEF SYSTEM
    Manufacturer
    SAVIA LIMITED
    Date Cleared
    2012-09-04

    (299 days)

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

    SAVIA LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.
    Device Description
    The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The EM-38 is a selectable dual channel TENS device operated by 4.5 V (3xAAA-Alkaline batteries). It comes with a convenient belt that features 4 sewn-in permanent electrodes and build-in wires and a receptacle for the control unit. There are 4 selectable pre-programmed output waveforms to choose from and the intensity levels are adjustable from 0 to 152 mA. Running times can be adjusted from 22 to 31 min. Other information displayed on the LCD display are operation mode, output waveform (programs) output strength, time remaining and battery low warning. A lock function provides extra safety for the user.
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