Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015697152

FEI Number

3015697152

Entity Name

SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

2&3/F,Building A, No.3 FuXing Yi Lane, HeHua Community, PingHu Street, LongGang District, Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ShenZhen ZhengKang Technology Co., Ltd. (Owner Number: 10062909)

Owner / Operator Contact Address

2&3/F,Building A, No.3 FuXing Yi Lane, HeHua Community, PingHu Street, LongGang District, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191894

PMA Number

N/A

All Registered Proprietary Names

Infrared Forehead Thermometer Sport-Type Pulse Oximeter Oximeter(Model: JZK-301A, JZK-302, JZK-303A, JZK-304, JZK-305A, JZK-306, JZK-307A, JZK-308, JZK-309A) Thermometer kit Upper Arm Blood Pressure Monitor, Models: ZK-B881, ZK-B882, ZK-B883, ZK-B885 Upper Arm Blood Pressure Monitor, Models: ZK-B868, ZK-B869, ZK-B872,ZK-B876

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-04-01
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2025-02-27
PXH	Thermometer Kit	General Hospital	Class 2	880.2910	2020-04-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-13

Official Correspondent

Huayong Yang

US Agent Details

Xiongwei Wang Email: xwang1024@hotmail.com Phone: (206) 2957618

Related Public Records

Same Entity

ShenZhen ZhengKang 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015697152. Last updated year: 2026. Please use registration number 3015697152 when referencing this establishment in official correspondence.