Andon Health Co, Ltd.
FDA 510(k) & PMA Approved Devices — 31 products
Total Devices31
Categories8
Latest FDA decision2025-08-04
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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 |
No matching devices.
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