Andon Health Co, Ltd.
Andon Health Co, Ltd. appears in FDA public data with 0 recalls, 92 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 4, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 92
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251113 | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure | August 4, 2025 |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | December 20, 2024 |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pres | April 22, 2024 |
| K222869 | Arm Blood Pressure Monitor | February 15, 2023 |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | December 21, 2022 |
| K212598 | iHealth infrared Ear thermometer PT5 | January 28, 2022 |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | July 30, 2021 |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | July 29, 2021 |
| K202753 | iHealth Wireless No-Touch Forehead Thermometer | March 8, 2021 |
| K202791 | iHealth Clinical Digital Thermometer | January 5, 2021 |
| K201380 | Livocare Surgical Mask | October 7, 2020 |
| K200710 | Infrared PT2L Digital No-Touch Thermometer | October 1, 2020 |
| K200531 | iHealth Infrared No-Touch Forehead Thermometer | July 15, 2020 |
| K183535 | Fully Automatic Electronic Blood Pressure Monitor | June 4, 2019 |
| K183534 | Fully Automatic Electronic Blood Pressure Monitor | May 16, 2019 |
| K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Li | April 16, 2019 |
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | February 1, 2019 |
| K172862 | Portable ECG Monitor (ECG3) | July 24, 2018 |
| K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) | September 15, 2017 |
| K171062 | BP5S Wireless Blood Pressure Monitor | August 1, 2017 |