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510(k) Data Aggregation

    K Number
    K192161
    Device Name
    FastFit EMS System
    Manufacturer
    Date Cleared
    2020-01-22

    (166 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fast Fit LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FastFit EMS System is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The FastFit EMS System is Rx only.
    Device Description
    The EMS System is a series of electrical muscle stimulation (EMS) electrodes embedded in a compression textile body suit intended to be worn by a user during physical exercise. When operated, the device provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities. When operated, the device provides localized EMS pulses to major muscle groups at controllable intensities. The FastFit EMS system consists of the following primary components: - FastFit Exercise Suit - EMS Controller - Power Adaptor - FastFit Software Application The FastFit Exercise Suit is a full body compression garment made from a Nylon/Spandex stretch fabric that incorporates embedded electrodes over key muscle groups. These electrodes are constructed of a conductive fabric sewn over a foam pad. Each electrode is connected via an integrated set of wiring leads sewn into the suit fabric that connect to a central contact pad at the right hip of the suit. A suit-to-controller connector at the central contact pad has 10 pairs of pins that act as lead contacts. Once connected to the suit, the EMS controller can deliver EMS pulses at the programmed intervals. EMS pulse intensity and target locations are controlled via a Bluetooth connection with a user's smartphone installed with the FastFit software application. A graphic user interface displayed on the touchscreen of the smartphone allows for the user to customize the stimulation program parameters at their discretion. After stimulation parameters have been set by the user with the software application, the parameters are uploaded to the EMS controller, and stimulation can be started anytime at the discretion of the user. The EMS controller is powered by a rechargeable lithium ion battery. A separate with an AC power adapter is provided to recharge the EMS controller when not in use.
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