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510(k) Data Aggregation

    K Number
    K190966
    Device Name
    Katalyst Training System
    Manufacturer
    Katalyst Inc.
    Date Cleared
    2020-02-03

    (297 days)

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

    Katalyst Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Katalyst Training System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
    Device Description
    The Katalyst Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate your muscles and help to improve muscle performance. Specifically, it uses neuromuscular electrical stimulation (NMES) to stimulate motor nerves, creating a muscle contraction to recruit more muscle fibers while training. It is designed to be used with the Katalyst Application, which is the interface between the user and the Impulse Pack and runs on a user supplied iOS device communicates wirelessly with the Impulse Pack using Bluetooth 4.2.
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    K Number
    K181199
    Device Name
    Katalyst Mark 1 Muscle Stimulation System Model 2
    Manufacturer
    Katalyst Inc.
    Date Cleared
    2018-09-20

    (136 days)

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

    Katalyst Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katalyst Mark 1 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 training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only.
    Device Description
    The Katalyst Mark 1 Muscle Stimulation System Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components: Katalyst Suit, Impulse Pack, and Katalyst Training Station. The Katalyst Suit is worn by the client and contains electrodes for major muscle groups. The Impulse Pack is a powered muscle stimulation device that connects to the suit and delivers EMS impulses. The Katalyst Training Station is a computer-based system with a touch screen and rotary encoders used to configure and run training sessions and adjust intensity levels.
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    K Number
    K171035
    Device Name
    Katalyst Mark 1 Muscle Stimulation System
    Manufacturer
    Katalyst Inc.
    Date Cleared
    2017-09-06

    (153 days)

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

    Katalyst Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Katalyst Mark 1 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 training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only.
    Device Description
    The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components: Katalyst Suit: Worn by the client, the Katalyst Suit is a compression textile with embedded electrodes connected by a cable harness. When connected to the Impulse Pack it provides localized EMS impulses to major muscle groups at controllable intensities. Impulse Pack: A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers electrical impulses through a battery powered regulated booster. The Impulse Pack is operator controlled wirelessly via the Katalyst Application over Bluetooth. Katalyst Application: Controlled by the Operator, the Katalyst Application is run on a Microsoft Surface Pro 3 running Windows 10 Professional. It is used to configure and run a Katalyst training, including the setting of independent intensities for each muscle group channel. Accessories included: cable harnesses and an Impulse Pack charging cable.
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