Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K132993
    Device Name
    COUNTER OTC TENS DEVICE
    Manufacturer
    COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.
    Date Cleared
    2014-04-24

    (212 days)

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

    COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This TENS Device is to be used for temporary relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities.
    Device Description
    The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading. The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device. The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.
    Ask a Question

    Page 1 of 1