Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008573045

FEI Number

3008573045

Entity Name

Andon Medical co., LTD

City/State/Country

Tianjin, CN

Establishment Address

NO.26 HANGYU ROAD, TIANJIN AIRPORT ECONOMIC AREA, TIANJIN , TIANJIN , 300381 , CHINA, Tianjin 300381, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ANDON MEDICAL CO.,LTD (Owner Number: 10033742)

Owner / Operator Contact Address

No.26 Hangyu Road,, Tianjin Airport Economic Area, TIANJIN, CN-TJ 300381, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iHealth (model: PT9L) iHealth (model: PT1) Infrared Digital No-Touch Thermometer (model:PT2L) iHealth (model: PT3SBT) iHealth (model: PT3) Infrared No-Touch Forehead Thermometer (model:PT9L) iHealth (model: PT2L) iHealth Infrared No-Touch Forehead Thermometer (model:PT9S) iHealth(model: AD-2126) SmartHeart (model: 01-5811) SmartHeart (model: 01-5812) SmartHeart (model: 01-5817) Exchange Select (model: 88-554) amazon basic+care (model: 44-553) Good Neighbor (model: 90-554) SmartHeart (model: 01-554) SmartHeart (model: 01-5811T) iHealth Jurni Connected Blood Pressure Monitor (Model: BP-300CL) good neighbor (model: 90-553) SmartHeart (model: 01-539WR) iHealth Track Pro Connected Blood Pressure Monitor (Model: KN-550LT) Meijer (model: 74-553) TOP CARE (model: 52-553) Meijer (model: 74-554) SmartHeart (model: 01-553NP) SmartHeart (model: 01-553) SmartHeart (model: 01-539) Discount Drug (model: 71-553) Best Choice (model: 41-553) Exchange Select (model: 88-553) Care One (model: 67-553) Discount Drug (model: 71-554) Wrist Blood Pressure Monitor, Blood Pressure Monitor(KD-752) Quality Choice(model: 89-743T) SmartHeart(model: 01-743T) Insect Bite Healer (model: IBH-1000) IHEALTH FINGERTIP PULSE OXIMETER(PO3M) iHealth (model: BP5S) iHealth (model: PO3) PULSE OXIMETER (model: PO6) PULSE OXIMETER (model: PO6L) iHealth (model: BPM1) iHealth (model: KD-723) iHealth COVID-19/Flu A&B Rapid Test amazon basic+care (model: 44-541) SmartHeart (model: 01-541) TOP CARE(model: 52-541) WRIST BLOOD PRESSURE MONITOR (model: KD-7920) Exchange Select(model: 88-541) iHealth Fresh Electric Nasal Wash System (model: ANC1) iHealth BP3L Wireless Blood Pressure Monitor iHealth (model: BP7S) ARM BLOOD PRESSURE MONITOR (model: KD-5920TL) iHealth (model: HS2S Pro) iHealth Nexus (Model: HS2S) SmartHeart(model: 01-540) iHealth Early Pregnancy Test Strip iHealth Early Pregnancy Test AG-607 Multi Blood Glucose Monitoring System AG-607 Blood Glucose Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-22
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2026-05-25
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-08-29
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2024-08-29
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-08-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-08-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-05-05
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-08-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-07-12
OSG	Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch	Neurology	Class 2	882.5894	2025-12-18
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-07-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-10-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-02-05
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2022-07-06
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	2017-05-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-03-19
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-05-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-04-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-09-12
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-09-12
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	2022-04-14
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	2019-07-12
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	2014-08-05
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-01-02
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-01-28
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2019-01-28

Official Correspondent

Guijun Ren

US Agent Details

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

Related Public Records

Same Entity

ANDON MEDICAL 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
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
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.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008573045. Last updated year: 2026. Please use registration number 3008573045 when referencing this establishment in official correspondence.