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510(k) Data Aggregation

    K Number
    K160893
    Device Name
    HANAROCare ReJu
    Manufacturer
    M.I.TECH CO.,LTD
    Date Cleared
    2016-07-27

    (118 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K140650,K140168,K141260,K122744
    Why did this record match?
    Reference Devices :

    K140650, K140168, K141260

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

    HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

    Device Description

    HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.

    AI/ML Overview

    The provided text describes the Hanarocare Reju, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria for device performance in a clinical study specifically, nor a study proving it meets such criteria in terms of efficacy on patients.

    The "Performance Data" section details various engineering, electrical, biocompatibility, and usability tests, but these are about the device's technical specifications, safety, and user-friendliness, not its clinical effectiveness against specific pain relief metrics.

    Therefore, the requested information elements cannot be fully extracted from the provided document.

    However, I can extract the information related to the performance data and usability in a structured way:

    1. Table of Acceptance Criteria and Reported Device Performance

    Note: The document does not provide specific acceptance criteria or reported performance for clinical efficacy (e.g., pain reduction levels). Instead, it lists various tests performed and implies that the measured values meet general "criteria" for performance characteristics. The table below focuses on the tests mentioned and their objectives.

    Acceptance Criteria (Implied Objective)Reported Device Performance (Summary of Study Findings)
    Shelf Life: Maintain quality for 2 yearsPassed: Visual Inspection, Gel Pad Adhesive Strength Test, Electrical Conductivity Test validated 2-year shelf life.
    Biocompatibility: Safe for skin contactPassed: Cytotoxicity Test (ISO 10993-5), Primary skin irritation study (ISO 10993-10), Contact Hypersensitivity (ISO 10993-10) for gel pad.
    Electrical Safety: Meet medical standardsPassed: Evaluated according to IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-1-2, IEC 62366, IEC 62304 standards.
    Physical Durability/Transport: Withstand stressPassed: Atmospheric Preconditioning, Atmospheric Conditioning, Compression, Vibration, Shock tests (ISTA 2014 Integrity Test Procedure 2A).
    Material Composition: RoHS compliancePassed: RoHS verification (IEC 62321:2008).
    Stimulus Output Characteristics: Meet specified parametersPassed: Performance test conducted to evaluate characteristic parameters of the stimulus output waveform; verified that measurement values meet the criteria.
    Usability: Easy for users to operatePassed: Usability study demonstrated "ease to use the HANAROCare ReJu."
    Safety Feature: Cut-off output above 3kΩ resistive loadReported: Device reduces and cuts off output (to less than 15V at open load) when detecting >3kΩ, with LED/buzzer alarm and automatic shutdown after 3 mins. This is a safety feature and does not affect performance.

    Regarding the specific questions that cannot be answered from the provided text:

    1. Sample size used for the test set and the data provenance:

      • For the usability study: 30 users of various age, gender, and educational backgrounds.
      • For other tests (shelf life, biocompatibility, electrical, physical durability, RoHS, performance test): Sample sizes are not specified.
      • Data provenance: Not specified.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical effectiveness study with a "ground truth" (e.g., expert-assessed pain levels, clinical outcomes) is described. The tests are technical compliance and user experience.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical effectiveness study requiring adjudication is described.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/imaging device.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical efficacy. For technical tests, the "ground truth" is defined by the technical specifications and standards (e.g., IEC standards, ISO standards).

    7. The sample size for the training set: Not applicable, as no machine learning or similar model requiring a training set is described.

    8. How the ground truth for the training set was established: Not applicable.

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