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Andon Health Co, Ltd.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31
Categories8
Latest Approval2025-08-04
TypeNumberDevice NameCodeDate
510(k) K251113 iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr DXN 2025-08-04 View
510(k) K241394 iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip LCX 2024-12-20 View
510(k) K234041 Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) DXN 2024-04-22 View
510(k) K222869 Arm Blood Pressure Monitor DXN 2023-02-15 View
510(k) K222867 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) NUH 2022-12-21 View
510(k) K212598 iHealth infrared Ear thermometer PT5 FLL 2022-01-28 View
510(k) K210768 Wrist Blood Pressure Monitor, Blood Pressure Monitor DXN 2021-07-30 View
510(k) K210770 Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor DXN 2021-07-29 View
510(k) K202753 iHealth Wireless No-Touch Forehead Thermometer FLL 2021-03-08 View
510(k) K202791 iHealth Clinical Digital Thermometer FLL 2021-01-05 View
510(k) K201380 Livocare Surgical Mask FXX 2020-10-07 View
510(k) K200710 Infrared PT2L Digital No-Touch Thermometer FLL 2020-10-01 View
510(k) K200531 iHealth Infrared No-Touch Forehead Thermometer FLL 2020-07-15 View
510(k) K183535 Fully Automatic Electronic Blood Pressure Monitor DXN 2019-06-04 View
510(k) K183534 Fully Automatic Electronic Blood Pressure Monitor DXN 2019-05-16 View
510(k) K181541 Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK MWI 2019-04-16 View
510(k) K181070 iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) NBW 2019-02-01 View
510(k) K172862 Portable ECG Monitor (ECG3) DSH 2018-07-24 View
510(k) K170231 iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) NBW 2017-09-15 View
510(k) K171062 BP5S Wireless Blood Pressure Monitor DXN 2017-08-01 View

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