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Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)March 5, 2026
K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)February 23, 2026
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)February 17, 2026
K242736Portable Oxygen Concentrator (Spirit-3)June 5, 2025
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)May 22, 2025
K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AApril 28, 2023
K221372YUWELL Electronic Blood Pressure MonitorOctober 17, 2022
K212385YUWELL Finger Pulse OximeterAugust 16, 2022
K203583YUWELL infrared ear thermometer: YHT101, YHT200May 20, 2021
K201864YUWELL Infrared ThermometerDecember 7, 2020
K200939Electronic Blood Pressure MonitorAugust 20, 2020
K170605Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, March 27, 2018
K120526YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIRMarch 8, 2012
K083559YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5BSeptember 4, 2009