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510(k) Data Aggregation

    K Number
    K250376

    Validate with FDA (Live)

    Device Name
    ViVY
    Date Cleared
    2025-11-05

    (268 days)

    Product Code
    Regulation Number
    890.5290
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VIVY™ is to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain and muscle spasms.

    Device Description

    The Vivy is used for diathermic heating of tissue. It consists of a compact, low-power, radio frequency (RF) generator contained within a garment to deliver therapeutic warming to injured tissues to facilitate the healing process. The power level and treatment time are adjustable. The device treatment is intended to be self-administered in the home.

    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. Continuous shortwave diathermy (CSWD) with the ViaTherm Vivy System produces therapeutic warming from within the tissues.

    The power generator consists of a battery pack, voltage regulators, a power control and analog sensor module, and an RF generator. A shielded 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.

    The Vivy contains the following components:

    • Rechargeable power generator containing a battery pack, regulator, power control, and analog sensor module
    • Garment belt
    • Heat applicator with dual RF coils
    • USB cable
    • Garment cable
    AI/ML Overview

    N/A

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