Andon Health Co L T D

FDA Filings

This page includes the latest FDA filings for Andon Health Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

CHINA

SHENZHEN STOCK EXCHANGE

002432

DUNS 421785478

FDA Registration(s)

• Registration Number: 3003741676
• FEI Number: 3003741676
• Name: Jeff Li
• Owner & Operator: ANDON HEALTH CO.,LTD
• Contact Address: No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT; TIANJIN CN-NOTA 300190 CN
• Official Correspondent:
  • YI - LIU
  • 86-22-60526161-x
• US Agent:
  • Jeff Li
  • iHealth Labs, Inc.
  • 650 2658459 0
  • 650 2922222
  • jeff@ihealthlabs.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 120 San Lucar Ct ; Sunnyvale, CA 94086 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

• Registration Number: 3008787503
• FEI Number: 3008787503
• Name: iHealth Labs, Inc.
• Owner & Operator: ANDON HEALTH CO.,LTD
• Contact Address: No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT; TIANJIN CN-NOTA 300190 CN
• Official Correspondent:
  • YI - LIU
  • 86-22-60526161-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 120 San Lucar Ct ; Sunnyvale, CA 94086 US

FDA Filings

Device Company	Device	Date
PMN K212598 Andon Health Co., Ltd.	IHealth Infrared Ear Thermometer PT5	2022-01-28
PMN K210768 Andon Health Co., Ltd.	Wrist Blood Pressure Monitor, Blood Pressure Monitor	2021-07-30
PMN K210770 Andon Health Co., Ltd.	Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor	2021-07-29
PMN K202753 Andon Health Co., Ltd.	IHealth Wireless No-Touch Forehead Thermometer	2021-03-08
PMN K202791 Andon Health Co., Ltd.	IHealth Clinical Digital Thermometer	2021-01-05
PMN K201380 Andon Health Co., Ltd.	Livocare Surgical Mask	2020-10-07
PMN K200710 Andon Health Co., Ltd.	Infrared PT2L Digital No-Touch Thermometer	2020-10-01
PMN K200531 Andon Health Co., Ltd.	IHealth Infrared No-Touch Forehead Thermometer	2020-07-15
PMN K183535 Andon Health Co., Ltd.	Fully Automatic Electronic Blood Pressure Monitor	2019-06-04
FRI Jeff Li [ANDON HEALTH CO.,LTD]	iHealth (model: HS4)	2019-05-29
PMN K183534 Andon Health Co., Ltd.	Fully Automatic Electronic Blood Pressure Monitor	2019-05-16
PMN K181541 Andon Health Co., Ltd	Connect App For IHealth Next, IHealth React Native SDK, IHealth React Native Library SDK, IHealth Library SDK, IHealth Native SDK	2019-04-16
PMN K181070 Andon Health Co., Ltd	IHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)	2019-02-01
PMN K172862 Andon Health Co., Ltd.	Portable ECG Monitor (ECG3)	2018-07-24
PMN K170231 Andon Health Co., Ltd	IHealth Align Gluco-Monitoring System (BG1); IHealth Wireless Smart Gluco-Monitoring System (BG5)	2017-09-15
PMN K171062 Andon Health Co., Ltd.	BP5S Wireless Blood Pressure Monitor	2017-08-01
PMN K171282 Andon Health Co., Ltd	Fully Automatic Blood Pressure Monitor	2017-07-27
PMN K153286 | NBW Jeff Li [ANDON HEALTH CO.,LTD]	iHealth (model:BG1)	2017-06-26
PMN K153286 | CGA Jeff Li [ANDON HEALTH CO.,LTD]	iHealth (model:BG1)	2017-06-26
PMN K163276 ANDON HEALTH CO.,LTD	Fully Automatic Electronic Blood Pressure Monitor	2017-05-11
PMN K153561 ANDON HEALTH CO., LTD	AG-607 Blood Glucose Monitoring System And AG-607 Multi Blood Glucose Monitoring System	2017-02-16
PMN K162668 ANDON HEALTH CO.,LTD	Fully Automatic Electronic Blood Pressure Monitor	2017-02-14
PMN K162915 Andon Health Co., Ltd.	Fully Automatic Electronic Blood Pressure Monitor	2017-02-08
PMN K162144 ANDON HEALTH CO.,LTD	IHealth Wireless Blood Pressure Monitor	2017-02-01
PMN K162230 | DXN Jeff Li [ANDON HEALTH CO.,LTD]	Medix(model:KD-5923)	2016-11-20
PMN K162230 | DXN Jeff Li [ANDON HEALTH CO.,LTD]	Medix(model: KD-5920)	2016-11-20
PMN K153286 Andon Health Co., Ltd	IHealth Align Gluco-Monitoring System	2016-08-19
PMN K153278 Andon Health Co., Ltd	Wireless Smart Gluco-Monitoring System	2016-08-19
PMN K160565 ANDON HEALTH CO., LTD	Fully Automatic Electronic Blood Pressure Monitor	2016-08-10
PMN K160563 ANDON HEALTH CO., LTD	Fully Automatic Electronic Blood Pressure Monitor	2016-08-04
PMN K131203 | NBW Jeff Li [ANDON HEALTH CO.,LTD]	iHealth Cloud	2016-04-03
PMN K131203 | MNW Jeff Li [ANDON HEALTH CO.,LTD]	iHealth Cloud	2016-04-03
PMN K131203 | DXN Jeff Li [ANDON HEALTH CO.,LTD]	iHealth Cloud	2016-04-03
PMN K160014 Andon Health Co., Ltd	IHealth Track Blood Pressure Monitor	2016-02-02
PMN K150833 ANDON HEALTH CO.,LTD	IHealth Align Gluco-Monitoring System, IHealth BG5 Wireless Smart Gluco-Monitoring System, IHealth BG5L Wireless Smart Gluco-Monitoring System	2015-12-04
PMN K152003 ANDON HEALTH CO.,LTD	IHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
PMN K152379 ANDON HEALTH CO.,LTD	IHealth View BP7S Wireless Blood Pressure Wrist Monitor	2015-09-23
PMN K151460 ANDON HEALTH CO., LTD.	Fully Automatic Electronic Blood Pressure Monitor	2015-09-08
PMN K150043 ANDON HEALTH CO.,LTD	Transcutaneous Electrical Nerve Stimulators (TENS)	2015-08-14
PMN K141984 ANDON HEALTH CO., LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2015-04-29
PMN K140121 ANDON HEALTH CO., LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2014-07-02
PMN K133790 ANDON HEALTH CO., LTD	IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM	2014-05-22
PMN K133117 ANDON HEALTH CO., LTD	ANDON BLOOD PRESSURE CUFF	2014-03-04
PMN K131111 ANDON HEALTH CO.,LTD	IHEALTH FINGERTIP PULSE OXIMETER	2013-09-11
PMN K131203 ANDON HEALTH CO., LTD	IHEALTH CLOUD	2013-07-19
PMN K122098 | MNW Jeff Li [ANDON HEALTH CO.,LTD]	iHealth Myvitals	2013-03-26
PMN K122098 | DXN Jeff Li [ANDON HEALTH CO.,LTD]	iHealth Myvitals	2013-03-26
PMN K122098 ANDON HEALTH CO., LTD	APPS-HEALTH01	2013-03-21
PMN K121697 ANDON HEALTH CO., LTD	FINGERTIP PULSE OXIMETER	2012-10-15
PMN K121372 ANDON HEALTH CO., LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2012-09-10
PMN K120896 ANDON HEALTH CO., LTD	WI-FI BODY SCALE	2012-07-26
PMN K121470 ANDON HEALTH CO., LTD	FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR	2012-06-14
PMN K120672 ANDON HEALTH CO.,LTD	KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR	2012-06-01
PMN K111830 ANDON HEALTH CO., LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO	2011-12-09
PMN K111826 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2011-12-09
PMN K110328 ANDON HEALTH CO.,LTD	ACG-8511 PORTABLE ECG MONITOR	2011-07-15
PMN K110018 ANDON HEALTH CO., LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2011-03-15
PMN K102939 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931	2011-02-23
PMN K110330 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2011-02-18
PMN K102690 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2010-11-24
PMN K102631 ANDON HEALTH CO.,LTD	KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2010-11-04
PMN K102930 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2010-11-03
PMN K102906 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2010-10-29
PMN K102356 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534	2010-09-20
PMN K102353 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513	2010-09-17
PMN K101950 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930	2010-08-31
PMN K101010 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008	2010-07-30
PMN K100940 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
PMN K100014 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557	2010-01-29
PMN K092811 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903	2010-01-13
PMN K092588 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918	2009-12-29
PMN K093452 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971	2009-12-23
PMN K092510 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911	2009-12-23
PMN K093528 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963	2009-12-04
PMN K093387 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902	2009-11-27
PMN K091739 ANDON HEALTH CO.,LTD	SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909	2009-08-18
PMN K091738 ANDON HEALTH CO.,LTD	SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD	2009-08-18
PMN K091737 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031	2009-08-18
PMN K091500 ANDON HEALTH CO.,LTD	MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556	2009-07-31
PMN K092045 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739	2009-07-30
PMN K091997 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962	2009-07-30
PMN K090772 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909	2009-06-04
PMN K090771 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962	2009-06-04
PMN K090769 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961	2009-06-04
PMN K090768 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,	2009-06-04
PMN K090963 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556	2009-04-30
PMN K083395 ANDON HEALTH CO.,LTD	SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598	2009-02-27
PMN K083319 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941	2009-01-29
PMN K083318 ANDON HEALTH CO.,LTD	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904	2009-01-29
PMN K083248 ANDON HEALTH CO.,LTD	FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902	2009-01-29
PMN K083247 ANDON HEALTH CO.,LTD	FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906	2009-01-29
PMN K083246 ANDON HEALTH CO.,LTD	FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961	2009-01-29
PMN K080326 ANDON HEALTH CO.,LTD	KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2008-07-31
PMN K073030 ANDON HEALTH CO.,LTD	AG-605 BLOOD GLUCOSE MONITORING SYSTEM	2008-07-21
PMN K080319 ANDON HEALTH CO.,LTD	KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR	2008-07-02

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092166711	Shanghai ,China (Mainland) -> Long Beach, California	BLOOD PRESSURE MONITOR BP3L IHEALTH TRACK BLO .	305 CTN
2020091113617	Pusan,South Korea -> Seattle, Washington	BLOOD PRESSURE MONITOR CY/DOOR	5168 CTN
2020091113617	Pusan,South Korea -> Seattle, Washington	BLOOD PRESSURE MONITOR CY/DOOR	5168 CTN
2020091113617	Pusan,South Korea -> Seattle, Washington	BLOOD PRESSURE MONITOR CY/DOOR	5168 CTN
2020091113617	Pusan,South Korea -> Seattle, Washington	BLOOD PRESSURE MONITOR CY/DOOR	5168 CTN
20200909114249	Shanghai ,China (Mainland) -> Long Beach, California	INFRARED NO-TOUCH FOREHEAD THERMOMETER	1890 CTN
2020090948241	Pusan,South Korea -> Los Angeles, California	BLOOD PRESSURE MONITOR & CUFF THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	3694 CTN
2020090948241	Pusan,South Korea -> Los Angeles, California	BLOOD PRESSURE MONITOR & CUFF THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	3694 CTN
20200909115895	Shanghai ,China (Mainland) -> Long Beach, California	IHEALTH WIRELESS PULSE OXIMETER	417 CTN
2020090293476	Xingang,China (Mainland) -> Long Beach, California	PRESSURE MONITOR	56 PCS
2020090171804	Pusan,South Korea -> Seattle, Washington	BLOOD PRESSURE MONITOR CY/DOOR	670 CTN
2020082458231	Pusan,South Korea -> Los Angeles, California	WYZE SCALE	463 CTN