Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133981
    Device Name
    AVACEN 100
    Manufacturer
    AVACEN INC.
    Date Cleared
    2014-08-15

    (232 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVACEN INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
    Device Description
    The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
    Ask a Question

    Page 1 of 1