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510(k) Data Aggregation

    K Number
    K062616
    Device Name
    WELLNESSPRO 2010
    Date Cleared
    2007-07-06

    (304 days)

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

    INTELSOURCE GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wellness Pro 2010 is an Electrotherapy Unit that is used for the following: 1. Relief of chronic, intractable pain. 2. Adjunctive treatment of post surgical or post-traumatic acute pain
    Device Description
    The Wellness Pro 2010 is designed to provide electrical stimulation, for the relief of chronic, intractable pain and as an adjunctive treatment of post-surgical or post-traumatic acute pain, in a single compact, lightweight user friendly package. Stimulation does not always cause sensation to relieve pain. The WellnessPro 2010 has 2 modes of waveforms: Continuous and Premodulated. The device gives the clinician ability to store frequencies or to choose from a set of 250 frequencies that allow quick and easy selection, for prescription of stimulation regimens that can be later stored in any of the 1000 available memory slots. The Wellness Pro 2010 package is comprised of the following items: - 1. 7.5 Volt medical power adapter, conforming to industry standards. - 2. Four industry standard wires for electrodes conforming to FDA standard, - 3. Four standard commercially available and FDA approved, round 50(mm) self adhesive electrodes. - 4. An instruction Manual.
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