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510(k) Data Aggregation

    K Number
    K220578
    Device Name
    Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
    Manufacturer
    Bozhou Rongjian Medical Appliance Co.,Ltd.
    Date Cleared
    2022-05-25

    (86 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K213879,K202893
    Why did this record match?
    Reference Devices :

    K213879

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

    The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.

    Device Description

    Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are implicitly derived from its substantial equivalence to the predicate device (K202893). The "Comparison" column in the table indicates "Same" or "Similar" for most parameters, meaning the new device's performance aligns with the established performance of the predicate. Note 1 explicitly addresses the difference in deviation from amplitude, frequency, and pulse width.

    ParameterAcceptance Criteria (Predicate Device K202893)Reported Device Performance (Model RJTENS-1)
    Indications for UseSame as predicateSame as predicate
    Type of UsePrescription usePrescription use
    Power Source(s)1.5Vx4 AAA alkaline battery1.5Vx4 AAA alkaline battery
    Method of Line Current IsolationN/AN/A
    Patient Leakage Current - Normal Condition2μΑ2μΑ
    Patient Leakage Current - Single Fault ConditionNANA
    Average DC current through electrodes
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