Andon Health Co., Ltd
Tianjin, CN
ANDON HEALTH CO., LTD appears in FDA device records in Tianjin, CN. FDA records list 92 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 92FDA records hold 92 510(k) clearances for Andon Health Co., Ltd between 2008 and 2025. The busiest year on record is 2009, with 24. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 3 |
| 2009 | 24 |
| 2010 | 11 |
| 2011 | 6 |
| 2012 | 5 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 6 |
| 2016 | 5 |
| 2017 | 8 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 3 |
| 2021 | 4 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | LCX | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K222869 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K222867 | AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) | NUH | Substantially Equivalent | |
| K212598 | iHealth infrared Ear thermometer PT5 | FLL | Substantially Equivalent | |
| K210768 | Wrist Blood Pressure Monitor, Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K210770 | Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K202753 | iHealth Wireless No-Touch Forehead Thermometer | FLL | Substantially Equivalent | |
| K202791 | iHealth Clinical Digital Thermometer | FLL | Substantially Equivalent | |
| K201380 | Livocare Surgical Mask | FXX | Substantially Equivalent | |
| K200710 | Infrared PT2L Digital No-Touch Thermometer | FLL | Substantially Equivalent | |
| K200531 | iHealth Infrared No-Touch Forehead Thermometer | FLL | Substantially Equivalent | |
| K183535 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K183534 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK | MWI | Substantially Equivalent | |
| K181070 | iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) | NBW | Substantially Equivalent | |
| K172862 | Portable ECG Monitor (ECG3) | DSH | Substantially Equivalent | |
| K170231 | iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) | NBW | Substantially Equivalent | |
| K171062 | BP5S Wireless Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K171282 | Fully Automatic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K163276 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K153561 | AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K162668 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K162915 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K162144 | iHealth Wireless Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K153286 | iHealth Align Gluco-Monitoring system | NBW | Substantially Equivalent | |
| K153278 | Wireless Smart Gluco-Monitoring System | NBW | Substantially Equivalent | |
| K160565 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K160563 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K160014 | iHealth Track Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System | NBW | Substantially Equivalent | |
| K152003 | iHealth BP3L Wireless Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K152379 | iHealth View BP7S Wireless Blood Pressure Wrist Monitor | DXN | Substantially Equivalent | |
| K151460 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K150043 | Transcutaneous Electrical Nerve Stimulators (TENS) | NUH | Substantially Equivalent | |
| K141984 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K140121 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K133790 | IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K133117 | ANDON BLOOD PRESSURE CUFF | DXQ | Substantially Equivalent | |
| K131111 | IHEALTH FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | |
| K131203 | IHEALTH CLOUD | DXN | Substantially Equivalent | |
| K122098 | APPS-HEALTH01 | DXN | Substantially Equivalent | |
| K121697 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | |
| K121372 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K120896 | WI-FI BODY SCALE | MNW | Substantially Equivalent | |
| K121470 | FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR | DXN | Substantially Equivalent | |
| K120672 | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K111830 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO | DXN | Substantially Equivalent | |
| K111826 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003741676 | 3003741676 | ANDON HEALTH CO., LTD | No. 3 Jin Ping Street,Ya An Road,, TIANJIN 300190 CN | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNWAnalyzer, Body Composition
- PUHAnalyzer, Body Composition, Exempt
- DXQBlood Pressure Cuff
- SDVClinical Electronic Thermometer
- DSKComputer, Blood-Pressure
- FLLContinuous Measurement Thermometer
- DPSElectrocardiograph
- LFRGlucose Dehydrogenase, Glucose
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter
- KMAIrrigator, Powered Nasal
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- FXXMask, Surgical
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- DQAOximeter
- OCHOximeter, Infrared, Sporting, Aviation
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch
- DSHRecorder, Magnetic Tape, Medical
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NYNStimulator, Electrical, Transcutaneous, For Arthritis
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Andon Health Co., Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain