Search Results
Found 11 results
510(k) Data Aggregation
K Number
K242736Device 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
868.5440Why 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
K250878Device 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
880.2910Why 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
K213825Device 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
868.5440Why 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
K221372Device 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
870.1130Why 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
K212385Device 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
870.2700Why 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
K203583Device 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
880.2910Why 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
K201864Device Name
YUWELL Infrared Thermometer
Manufacturer
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Date Cleared
2020-12-07
(154 days)
Product Code
FLL
Regulation Number
880.2910Why 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
K200939Device 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
870.1130Why 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
K170605Device Name
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
Manufacturer
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd
Date Cleared
2018-03-27
(391 days)
Product Code
DXN
Regulation Number
870.1130Why 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 at household or medical center. (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 series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.
Ask a Question
K Number
K120526Device 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
890.3850Why 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
Page 1 of 2