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510(k) Data Aggregation

    K Number
    K241119
    Device Name
    Transcutaneous Electrical Nerve Stimulator (K6106)
    Manufacturer
    Shenzhen Yicai Health Technology Co., Ltd.
    Date Cleared
    2024-07-22

    (90 days)

    Product Code
    NUH,NGX
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K171381,K171803,K192264,K201354,K191151
    Why did this record match?
    Device Name :

    Transcutaneous Electrical Nerve Stimulator (K6106)

    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 (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 and facilitate muscle performance.

    Device Description

    Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).

    The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.

    The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.

    In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.

    AI/ML Overview

    The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of filing does not contain detailed clinical study data or acceptance criteria in the format typically used for AI/ML device evaluations. Instead, it demonstrates substantial equivalence to predicate devices primarily through non-clinical performance and a comparison of technical specifications.

    Therefore, I cannot extract information related to acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not typically included or required in a non-clinical 510(k) submission for a TENS device.

    However, I can extract the available information regarding the device's technical specifications and how its performance is compared to predicate devices, focusing on the "Substantial Equivalence Comparison" tables.

    Here's a summary of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly define "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of predicate devices to establish substantial equivalence. The "reported device performance" refers to the subject device's specifications and its compliance with relevant international standards.

    Here's a table summarizing key technical specifications and their comparison to predicate devices, drawing from the "Substantial Equivalence Comparison" tables. "Acceptance Criteria" here are implicitly defined by the ranges and characteristics observed in the predicate devices and compliance with relevant standards.

    Element of ComparisonAcceptance Criteria (Implied by Predicate Range/Compliance)Reported Device Performance (Subject Device K6106)Comparison Result
    General
    Product CodeNUH, NGX, NYN, GZJ, IPF, IRT (covered by predicates)NUH, NGXSame (within the scope of predicate product codes)
    Regulation Number21 CFR 882.5890, 21 CFR 890.585021 CFR 882.5890, 21 CFR 890.5850Same
    Prescription/OTCOTCOTCSame
    Intended UseTemporary relief of pain (TENS); Muscle performance improvement (EMS) covering specific body partsIdentical to primary predicate for TENS and EMS indicationsSame
    Power SupplyInternal/rechargeable batteries (e.g., 3x1.5V AAA, 3.7V lithium)Internal battery: 3.7Vd.c. 300mAhSame (within typical battery specifications for such devices)
    Method of Line Current IsolationType BF/Battery supply/Voltage transformer isolationType BFSame (Type BF is a recognized isolation type)
    Patient Leakage Current
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