Andon Health Co, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
92
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251113iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood PressureAugust 4, 2025
K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripDecember 20, 2024
K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood PresApril 22, 2024
K222869Arm Blood Pressure MonitorFebruary 15, 2023
K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)December 21, 2022
K212598iHealth infrared Ear thermometer PT5January 28, 2022
K210768Wrist Blood Pressure Monitor, Blood Pressure MonitorJuly 30, 2021
K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorJuly 29, 2021
K202753iHealth Wireless No-Touch Forehead ThermometerMarch 8, 2021
K202791iHealth Clinical Digital ThermometerJanuary 5, 2021
K201380Livocare Surgical MaskOctober 7, 2020
K200710Infrared PT2L Digital No-Touch ThermometerOctober 1, 2020
K200531iHealth Infrared No-Touch Forehead ThermometerJuly 15, 2020
K183535Fully Automatic Electronic Blood Pressure MonitorJune 4, 2019
K183534Fully Automatic Electronic Blood Pressure MonitorMay 16, 2019
K181541Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth LiApril 16, 2019
K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)February 1, 2019
K172862Portable ECG Monitor (ECG3)July 24, 2018
K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)September 15, 2017
K171062BP5S Wireless Blood Pressure MonitorAugust 1, 2017