Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017424877

FEI Number

3017424877

Entity Name

DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

4th floor, building D, Yizhong Science Park, 83 Jinsha 2nd Road, Shuikou village, Dalang Town, Dongguan City,, Dongguan Guangdong 523770, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan kangweile Electronic Technology Co., Ltd (Owner Number: 10083307)

Owner / Operator Contact Address

4th floor, building D, Yizhong Science Park, 83 Jinsha 2nd Road, Shuikou village, Dalang Town, Dongguan City,, Dongguan, CN-GD 523770, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230642

PMA Number

N/A

All Registered Proprietary Names

Electronic Blood Pressure MonitorKWL-W01.KWL-W02.KWL-W03.KWL-W06.KWL-W08.KWL-W09.KWL-W01L Electronic Blood Pressure MonitorKWL-W01. Electronic Blood Pressure MonitorKWL-B118.KWL-B106 Electronic Blood Pressure Monitor (Arm Type) KWL-B01.KWL-B02.KWL-B03.KWL-B04.KWL-B05.KWL-B06.KWL-B07.KWL-B08.KWL-B09 Electronic Blood Pressure Monitor (Arm Type) KWL-B112.KWL-B168.KWL-B01L.KWL-B116.KWL-B606.KWL-B808.KWL-B698.KWL-B816 Electronic Blood Pressure MonitorKWL-B619.KWL-B13.KWL-B15.KWL-B18.KWL-B17 Electronic Blood Pressure Monitor (Arm Type) KWL-818.KWL-819.KWL-B819L.KWL-B21L.KWL-B22L.KWL-819L

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	2021-11-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-08-14

Official Correspondent

Zhixin Gao

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Dongguan kangweile Electronic Technology 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.

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 3017424877. Last updated year: 2026. Please use registration number 3017424877 when referencing this establishment in official correspondence.