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510(k) Data Aggregation

    K Number
    K223825
    Device Name
    Tens & Ems Device
    Manufacturer
    Shenzhen Jian Feng Electronic Technology Co., Ltd
    Date Cleared
    2023-05-09

    (139 days)

    Product Code
    NUH,NGX
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    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

    The provided document is a 510(k) clearance letter from the FDA for a Tens & Ems Device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

    The content of the document is a regulatory approval notice, focusing on:

    • The device being cleared (Tens & Ems Device).
    • The regulation number and product codes.
    • The indications for use (temporary pain relief for TENS, muscle stimulation for EMS).
    • Its classification as an Over-The-Counter device.
    • General FDA regulatory compliance information.

    Therefore, I cannot provide the requested information from the given text. To answer your questions, details from the actual performance study report, which would have been part of the 510(k) submission, would be necessary.

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