Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003741676

FEI Number

3003741676

Entity Name

ANDON HEALTH CO., LTD

City/State/Country

TIANJIN, CN

Establishment Address

No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT, TIANJIN 300190, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ANDON HEALTH CO.,LTD (Owner Number: 9055208)

Owner / Operator Contact Address

No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT, TIANJIN, CN-NOTA 300190, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163276

PMA Number

N/A

All Registered Proprietary Names

AG-607 Multi Blood Glucose Monitoring System iHealth Acacia Blood Glucose Monitoring System (model:AG-607) iHealth Early Pregnancy Test Strip iHealth Early Pregnancy Test iHealth Cloud iHealth BP3L Wireless Blood Pressure Monitor iHealth (model: BP7S) MEDLINE(model: MDS8001BXL) iHealth Accu Luminate Connected Blood Pressure Monitor (model: KD-5811BT) MEDLINE(model: MDS8001B) iHealth Accu Connected Blood Pressure Monitor (model: KD-5811BT) Wrist Blood Pressure Monitor, Blood Pressure Monitor(KD-752) SmartHeart(model: 01-743T) Quality Choice(model: 89-743T) iHealth Soothe Dual-Channel TENS Unit (model:AD-2126) iHealth(model: AD-2126) Insect Bite Healer (model: IBH-1000) iHealth Track Blood Pressure Monitor IHEALTH FINGERTIP PULSE OXIMETER(PO3M) SmartHeart(model: 01-540) SmartHeart (model: 01-5811) SmartHeart (model: 01-5812) SmartHeart (model: 01-5817) iHealth Myvitals iHealth (model: BPM1) ARM BLOOD PRESSURE MONITOR (model: KD-5920TL) Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor(KD-552) iHealth Neo Wireless Blood Pressure Monitor(model: BP5S) iHealth (model: HS2S Pro) iHealth Nexus (Model: HS2S) iHealth Push Wrist Blood Pressure Monitor (model: KD-723)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-01-25
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2019-01-25
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-01-02
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2016-04-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-04-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-04-03
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-07-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-09-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-09-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-09-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-08-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-05-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-08-21
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2024-08-21
OSG	Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch	Neurology	Class 2	882.5894	2025-12-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-07-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-10-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-08-27
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-09-20
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-09-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-09-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-05-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-07-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-09-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2013-03-26
MNW	Analyzer, Body Composition	Cardiovascular	Class 2	870.2770	2013-03-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-03-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-02-05
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2019-09-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-05-17

Official Correspondent

YI LIU

US Agent Details

Yange Wang Business: IHEALTH LABS, INC Email: policy@ihealthlabs.com Phone: (408) 6638349

Related Public Records

Same Entity

ANDON HEALTH CO.,LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
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
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003741676. Last updated year: 2026. Please use registration number 3003741676 when referencing this establishment in official correspondence.