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Andon Health Co, Ltd. FDA Approvals
0 new drug approvals and 10 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| 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 Pr510(k)Aug 4, 2025Cardiovascular |
| iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip510(k)Dec 20, 2024Clinical Chemistry |
| 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)510(k)Apr 22, 2024Cardiovascular |
| Arm Blood Pressure Monitor510(k)Feb 15, 2023Cardiovascular |
| AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)510(k)Dec 21, 2022Neurology |
| iHealth infrared Ear thermometer PT5510(k)Jan 28, 2022General Hospital |
| Wrist Blood Pressure Monitor, Blood Pressure Monitor510(k)Jul 30, 2021Cardiovascular |
| Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor510(k)Jul 29, 2021Cardiovascular |
| iHealth Wireless No-Touch Forehead Thermometer510(k)Mar 8, 2021General Hospital |
| iHealth Clinical Digital Thermometer510(k)Jan 5, 2021General Hospital |