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    K Number
    K172897
    Device Name
    Neck Care Therapy, Model: SYK 509B
    Manufacturer
    Shenzhen OSTO Technology Co., Ltd.
    Date Cleared
    2018-12-07

    (441 days)

    Product Code
    NUH,NGX
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K133929
    Why did this record match?
    Device Name :

    Neck Care Therapy, Model: SYK 509B

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

    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

    • Neck Pad is used in back of neck.
    • Meridian Pad is used in shoulder, waist, back, and arm.
    Device Description

    This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.

    The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.

    The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.

    The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

    The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.

    The remote control is the only controller to select the pulse intensity and adjust the treatment time.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (Neck Care Therapy, Model: SYK-509B) and does not contain a study that proves the device meets acceptance criteria in the manner described by your request (e.g., a clinical trial with a test set, ground truth established by experts, MRMC studies, or standalone performance evaluation).

    Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Health Expert Electronic Stimulator, K133929) primarily through bench testing for safety and performance specifications, and a comparison of technical characteristics and intended use.

    Here's an analysis based on the information provided, highlighting what is and is not present:

    Key Takeaways from the document:

    • This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, intended for Over-The-Counter Use.
    • The primary method of demonstrating equivalence is through engineering bench tests of electrical safety, EMC, biocompatibility, usability, software verification, and waveform output.
    • There is no mention of a clinical study involving human subjects or expert readers to evaluate the device's therapeutic effectiveness for pain relief, nor is there a direct assessment of its performance against a predefined "acceptance criteria" for clinical outcomes. The "acceptance criteria" in this context are primarily related to meeting safety standards and having comparable technical specifications to the predicate device.

    Detailed Breakdown based on your Request (with notations on missing information):

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryAcceptance Criteria (What was needed to pass)Reported Device Performance (How the device performed)
    Electrical SafetyCompliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards."Comply with IEC 60601-1 and 60601-2-10"
    Electromagnetic Compatibility (EMC)Compliance with IEC 60601-1-2 standard."Comply with IEC 60601-1-2"
    BiocompatibilityCompliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) for user-contacting materials."Biocompatibility test according to ISO 10993-5 and ISO 10993-10" (Implies successful compliance)
    UsabilityCompliance with IEC 62366 standard."Usability test according to IEC 62366 standard" (Implies successful compliance)
    Software Verification & ValidationCompliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.""Software verification and validation test according to the requirements..." (Implies successful compliance)
    Waveform Output SpecificationsCompliance with "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning" for output current, voltage, pulse duration, frequency, net charge, phase charge, AVG current, etc."The waveform test has also been conducted to verify the output specifications..." (Detailed comparison table with predicate shows identical/similar values for key output parameters)
    Leakage CurrentComparable to predicate device (NC AC: 54.5uA, DC: 0.5uA; SFC AC: 120uA, DC: 0.6uA).Identical to predicate device values.
    Average Current (no pulses)
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