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510(k) Data Aggregation

    K Number
    K123866
    Device Name
    TANYX
    Manufacturer
    Date Cleared
    2013-09-13

    (270 days)

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

    MEDECELL US, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used in adults only for temporary relief of pain associated with sore and aching muscles in the upper extremities (arms), lower extremities (legs), and lower back due to strain from exercise or normal household and work activities.
    Device Description
    TANYX® is based on TENS medical technology. The product is to reduce or eliminate pain through the emission of controlled and focused electrical signals. It is a disposable device, designed to be sold directly to consumers for the temporary relief of pain. TANYX® adheres to a person's skin and emits either a fixed or modulated electrical signal through a grid of integrated electrodes. It is a product which is characterized as portable, inexpensive, disposable, and (compared to other TENS-based products) easy to handle and operate. No medical supervision is required.
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