FDA.reportPublic FDA data

ANDON HEALTH CO., LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037416763003741676ANDON HEALTH CO., LTD1N2026-01-01No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT TIANJIN CN 300190

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
615651472109726K251113iHealth 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 PrDXN2025-08-04
615651185217173K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX2024-12-20
615651929357545K234041Fully 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)DXN2024-04-22
615651075810766K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)NUH2022-12-21
615651390195900K222034RightLance Blood Lancing SystemQRL2022-09-07
615651964075302K212598iHealth infrared Ear thermometer PT5FLL2022-01-28
615651658491274K210770Arm Blood Pressure Monitor, Wireless Blood Pressure MonitorDXN2021-07-29
615651724076882K210768Wrist Blood Pressure Monitor, Blood Pressure MonitorDXN2021-07-30
615651871405182K202791iHealth Clinical Digital ThermometerFLL2021-01-05
615651504102192K202753iHealth Wireless No-Touch Forehead ThermometerFLL2021-03-08
615651815755391K200710Infrared PT2L Digital No-Touch ThermometerFLL2020-10-01
615651050758862K200531iHealth Infrared No-Touch Forehead ThermometerFLL2020-07-15
615651710169551K183535Fully Automatic Electronic Blood Pressure MonitorDXN2019-06-04
615651296197952K183534Fully Automatic Electronic Blood Pressure MonitorDXN2019-05-16
615651987790891K181070iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)NBW2019-02-01
615651501004786K172862Portable ECG Monitor (ECG3)DSH2018-07-24
615651503833975K171282Fully Automatic Blood Pressure MonitorDXN2017-07-27
615651239145706K171062BP5S Wireless Blood Pressure MonitorDXN2017-08-01
615651266508531K170231iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)NBW2017-09-15
615652000645230K163276Fully Automatic Electronic Blood Pressure MonitorDXN2017-05-11
615651038793282K162915Fully Automatic Electronic Blood Pressure MonitorDXN2017-02-08
615651944491770K162230Fully Automatic Electronic Blood Pressure MonitorDXN2016-11-18
615652008720556K162144iHealth Wireless Blood Pressure MonitorDXN2017-02-01
615651511283466K160565Fully Automatic Electronic Blood Pressure MonitorDXN2016-08-10
615651432794509K160014iHealth Track Blood Pressure MonitorDXN2016-02-02
615651498504644K153561AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemNBW2017-02-16
615651895000844K153286iHealth Align Gluco-Monitoring systemNBW2016-08-19
615651734532003K152379iHealth View BP7S Wireless Blood Pressure Wrist MonitorDXN2015-09-23
615651825507413K152003iHealth BP3L Wireless Blood Pressure MonitorDXN2015-09-24
615651712892308K151460Fully Automatic Electronic Blood Pressure MonitorDXN2015-09-08
615651425240595K141984FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXN2015-04-29
615651405083274K133117ANDON BLOOD PRESSURE CUFFDXQ2014-03-04
615652021631959K131203IHEALTH CLOUDDXN2013-07-19
615651018276421K131111IHEALTH FINGERTIP PULSE OXIMETERDQA2013-09-11
615651650583490K122098APPS-HEALTH01DXN2013-03-21
615651042404445K120672KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITORDXN2012-06-01
615651144292756K110018FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXN2011-03-15
615651585896801K102906FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXN2010-10-29
615651815324745K102690FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITORDXN2010-11-24
615651200713837K092045FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739DXN2009-07-30
615651892912415K091997FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962DXN2009-07-30
615651976665458K091737FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031DXN2009-08-18
615651818495185K083318FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904DXN2009-01-29
615651061178711K083248FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902DXN2009-01-29
615651530417502
615651048920486
615651072421432
615651076771569
615651265673927
615651298394531
615651388967174
615651889950602
615651997943525

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN372025-08-04
FLL52022-01-28
NBW42019-02-01
LCX12024-12-20
NUH12022-12-21
QRL12022-09-07
DSH12018-07-24
DXQ12014-03-04
DQA12013-09-11

PMN#