Chrysalis Intelligence · Sponsors · Andon Health Co, Ltd.

Andon Health Co, Ltd.

Tianjin, CN · 13 510(k) clearances

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Total clearances
13
2020-07-15 → 2025-08-04
Last 12 months
0
Product codes
5
Most recent
2025-08-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DXN System, Measurement, Blood-Pressure, Non-Invasive Class II Cardiovascular 5 2025-08-04
FLL Continuous Measurement Thermometer Class II General Hospital 5 2022-01-28
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Class II Clinical Chemistry 1 2024-12-20
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Class II Neurology 1 2022-12-21
FXX — — — 1 2020-10-07
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2025-08-04 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 Class II Cardiovascular
2024-12-20 K241394 iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip LCX Class II Clinical Chemistry
2024-04-22 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 Class II Cardiovascular
2023-02-15 K222869 Arm Blood Pressure Monitor DXN Class II Cardiovascular
2022-12-21 K222867 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) NUH Class II Neurology
2022-01-28 K212598 iHealth infrared Ear thermometer PT5 FLL Class II General Hospital
2021-07-30 K210768 Wrist Blood Pressure Monitor, Blood Pressure Monitor DXN Class II Cardiovascular
2021-07-29 K210770 Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor DXN Class II Cardiovascular
2021-03-08 K202753 iHealth Wireless No-Touch Forehead Thermometer FLL Class II General Hospital
2021-01-05 K202791 iHealth Clinical Digital Thermometer FLL Class II General Hospital
2020-10-07 K201380 Livocare Surgical Mask FXX — —
2020-10-01 K200710 Infrared PT2L Digital No-Touch Thermometer FLL Class II General Hospital
2020-07-15 K200531 iHealth Infrared No-Touch Forehead Thermometer FLL Class II General Hospital
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence