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510(k) Data Aggregation

    K Number
    K173300
    Device Name
    ViaTherm BOOST
    Manufacturer
    ViaTherm Therapeutics, Llc.
    Date Cleared
    2018-05-01

    (196 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ViaTherm Therapeutics, Llc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
    Device Description
    The ViaTherm BOOST Diathermy System is a single-patient reusable device designed to be self-administered in the home by a non-technical, adult operator. Diathermy is the controlled production of "deep heating" beneath the skin in the subcutaneous tissues, deep muscles and joints for therapeutic purposes. The ViaTherm BOOST Diathermy System is a portable diathermy heat therapy system that uses a shortwave radiofrequency signal to provide diathermic heating of tissue. The ViaTherm BOOST Diathermy System consists of five (5) components: Power generator, Heat applicator garment, Battery charging cable, Velcro extender strap, Cotton pad. Electronic circuitry in the power generator components generates a radiofrequency (RF) signal at a frequency of 13.56 Megahertz (MHz). The radiofrequency signal is delivered to the heat applicator garment that uses induction coil (magnetic field) technology to produce electromagnetic fields external to the applicator. This energy is converted into heat by electromagnetically resistant body tissues. The power generator consists of a battery pack, voltage regulators, a power control and analogue sensor module, and an RF generator. A shielded 1/4" cable with 50 Ohms impedance connects the power generator to the heat applicator garment. The electrode consists of two flat spirals incorporated into the applicator garment. The spirals are each tuned to 50 Ohms. The power from the generator is split and sent to the two spirals, one of which is driven 180 degrees out of phase from the other.
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