Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K242736
    Device Name
    Portable Oxygen Concentrator (Spirit-3)
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., LTD.
    Date Cleared
    2025-06-05

    (267 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.
    Device Description
    Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.
    Ask a Question
    K Number
    K250878
    Device Name
    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
    Date Cleared
    2025-05-22

    (59 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Ear Thermometer is indicated for intermittent measurement of human body temperature from the ear canal. The device can be used by people of all ages except preterm babies or babies who are small for gestational age. The thermometer is intended for use in professional settings and the home environment. It is not for emergency clinical conditions.
    Device Description
    YUWELL® Infrared Ear Thermometer is designed to measure human body temperature. This hand-held, no-contact device is battery-powered and utilizes infrared energy emitted in the subject's tympanic membrane to determine human body temperature. The thermometer provides temperature readings in just 2 seconds. It is suitable for individuals of all ages except preterm babies or babies who are small for gestational age. The Infrared Ear Thermometer YHT107 can transmit the temperature readings via Bluetooth, whereas the YHT100 does not have data transmission capability.
    Ask a Question
    K Number
    K213825
    Device Name
    Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Cleared
    2023-04-28

    (506 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This oxygen concentrator is intended for using as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.
    Device Description
    The Yuyue Oxygen Concentrator models 8F-3A/8F-5A is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The subject device is intended use for adult population. The subject device contains primary electrical components including main unit, compressor, fan, flowmeter and circuit breaker, the software is moderate level according to FDA software guideline.
    Ask a Question
    K Number
    K221372
    Device Name
    YUWELL Electronic Blood Pressure Monitor
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply CO.,LTD.
    Date Cleared
    2022-10-17

    (158 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with wrist circumference ranging from 13.5 cm at household or medical center (not suitable for neonate, pregnancy or pre-eclampsia.)
    Device Description
    The YUWELL® Blood Pressure Monitor (Model: YE8800AR, YE8800CR) is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800AR, YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
    Ask a Question
    K Number
    K212385
    Device Name
    YUWELL Finger Pulse Oximeter
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Cleared
    2022-08-16

    (379 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.
    Device Description
    The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion. The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.
    Ask a Question
    K Number
    K203583
    Device Name
    YUWELL infrared ear thermometer: YHT101, YHT200
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
    Date Cleared
    2021-05-20

    (163 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YUWELL® Infrared ear thermometer is a non-sterile, reusable clinical thermometer. The device is to display the body temperature in the ear cavity by thermal radiation for people of all ages except preterm babies and newborns (1-29 days old).
    Device Description
    The YUWELL® Infrared ear thermometer is designed for measuring the body's temperature, is a hand-held non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's tympanic membrane that converts a user's body temperature.
    Ask a Question
    K Number
    K201864
    Device Name
    YUWELL Infrared Thermometer
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
    Date Cleared
    2020-12-07

    (154 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YUWELL® Infrared thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except preterm babies.
    Device Description
    The YUWELL® infrared thermometer is designed for measuring the body's frontal temperature, is a handheld non-contact infrared thermometer, battery powered, using the infrared energy emitted in the subject's forehead area within 0-5cm that converts a user's forehead temperature. The measurement reference sites is the center of the brow. The temperature measurement takes only 1 second, does not contact human skin. The infrared thermometer is intended for use on people of all ages except pre-term babies.
    Ask a Question
    K Number
    K200939
    Device Name
    Electronic Blood Pressure Monitor
    Manufacturer
    Jiangsu Yuyue Medical Equipment & Supply Co., Ltd
    Date Cleared
    2020-08-20

    (134 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Jiangsu Yuyue Medical Equipment **& Supply Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia)
    Device Description
    The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; the time, date, blood pressure value and pulse value are included. The record maybe revisited.
    Ask a Question
    K Number
    K120526
    Device Name
    YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
    Manufacturer
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
    Date Cleared
    2012-03-08

    (15 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    **JIANGSU YUYUE MEDICAL EQUIPMENT **& SUPPLY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YUYUE K2/K4 wheelchair is indicated for providing mobility to persons limited to a sitting position.
    Device Description
    The YUYUE K2/K4 wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The YUYUE K2/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
    Ask a Question
    K Number
    K083559
    Device Name
    YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
    Manufacturer
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
    Date Cleared
    2009-09-04

    (276 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    **JIANGSU YUYUE MEDICAL EQUIPMENT **& SUPPLY CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YuYue OxygenMax™ 7F-5 Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. It is intended to provide supplemental oxygen to patients with respiratory disorders for use in the home or health care facility. This device is available by prescription only and is not intended to support or sustain life.
    Device Description
    The Yuyue OxygenMax™ 7F-5 oxygen concentrator (" the Yuyue 7F-5") is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home or an institutional environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Yuyue 7F-5 provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 90% to 94%. The Yuyue 7F-5 uses a standard AC power of 120 V/60 Hertz. The Yuyue 7F-5 uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath The basic technology of The Yuyue 7F-5 is commonly used and equivalent to other FDA approved oxygen concentrators under the same Product Code of CAW. The principles of operation are equivalent to the predicate device.
    Ask a Question

    Page 1 of 1