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510(k) Data Aggregation

    K Number
    K242567
    Date Cleared
    2024-11-04

    (67 days)

    Product Code
    Regulation Number
    882.5890
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Muscle and Nerve Stimulator TENS & EMS device. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements.

    While it includes the "Indications for Use" for the device, it does not describe any specific performance acceptance criteria or details of a study conducted to demonstrate the device's performance against such criteria. Therefore, I cannot provide the requested table or the other study-related information.

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