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510(k) Data Aggregation

    K Number
    K233770
    Device Name
    Pepper EMS Training System
    Manufacturer
    Pepper Interactive Inc
    Date Cleared
    2025-01-16

    (419 days)

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

    Pepper Interactive Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pepper EMS 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 Pepper EMS 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.
    Device Description
    The Pepper EMS Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate healthy 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. The Pepper EMS Training System is the main part and consists of two separate accessories, the Pepper Suit and the Pepper Battery Box. The Pepper EMS Training System is designed to be used with the Pepper Application, which is the interface between the user and the Battery Box and runs on a user supplied iOS or Android device. The iOS or Android device communicates wirelessly with the Battery Box using Bluetooth 4.2.
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