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510(k) Data Aggregation

    K Number
    K250841
    Device Name
    Electrotherapy Electrodes
    Manufacturer
    Baisheng Medical Co., Ltd.
    Date Cleared
    2025-08-13

    (146 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K180865
    Why did this record match?
    Device Name :

    Electrotherapy Electrodes

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

    Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

    Device Description

    Electrotherapy Electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, flexible structures composed of laminated materials commonly used in the application:

    1st layer: Insulation material: Tan fabric
    2nd layer: Double sides adhesive tape
    3rd layer: Conductive film (Carbon Film)
    4th layer: Self-adhesive conductive hydrogel
    5th layer: Plastic release film
    Connection: Leadwire/Snap button

    The electrodes are designed for single-patient & single application use. Because of the adhesive nature of the conductive hydrogel, no securing materials are required to secure the device to the patient's skin.

    AI/ML Overview

    The provided FDA 510(k) clearance letter and summary for the Electrotherapy Electrodes (K250841) does not describe a study involving AI or human reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

    Therefore, many of the requested details about acceptance criteria for AI and human performance studies, expert involvement, adjudication, MRMC studies, standalone AI performance, and ground truth establishment cannot be found in this document.

    However, I can extract the acceptance criteria and performance data related to the non-clinical tests that were performed to demonstrate substantial equivalence for this device.

    Acceptance Criteria and Device Performance (Non-Clinical)

    The device, Electrotherapy Electrodes (K250841), is a Class II cutaneous electrode. The study described focuses on demonstrating its substantial equivalence to a predicate device (ZMI Self-Adhesive Electrodes, K180865) primarily through non-clinical performance and biocompatibility testing. No AI component or human reader study is discussed.

    1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

    Acceptance Criteria (Metric)Acceptance LimitReported Device Performance (Result)Study Description
    Electrical Performance
    A.C. Impedance≤ 160 ohmsNot explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed.Electrical performance was evaluated under IFU (Instructions for Use) normal use conditions. This likely involved measuring the A.C. Impedance of the electrodes. The acceptance limit for the predicate device was
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