Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020978007

FEI Number

3020978007

Entity Name

DONGGUAN BAO KANG DIAN ZI KE JI LIMITED

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

No. 8-1, Wen Yu Road, Zhangmutou Town, Dongguan City Guangdong /, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. (Owner Number: 9058334)

Owner / Operator Contact Address

Units 15-21, 12/F, Topsail Plaza,, 11 On Sum Street,, Shek Mun, Shatin, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

i-STAT Alinity Base Station i-STAT Printer Kit i-STAT Alinity Printer Kit i-STAT Alinity Battery i-STAT Portable Printer i-STAT 9V NiMH rechargeable battery Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System Theragun PRO PLUS Accuryn SmartFoley IAP UO Temp Tray System Accuryn SmartFoley UO Temp Tray System AccuTab Accuryn Monitoring System Theragun PRO PLUS G3PRO Theragun Pro Theragun Elite Theragun Prime Plus Theragun PRO PLUS I-STAT Dispensing Tip Theragun PRO PLUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-08-27
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2013-01-14
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2011-11-15
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2021-10-31
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2022-06-17
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2020-01-06
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2020-01-06
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2020-01-06
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2021-11-01
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2021-11-01
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2021-11-01
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2021-11-01
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2021-11-01
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-08-03
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-02-28
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2023-02-28
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2023-02-28
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2023-02-28
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2023-08-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-05-12
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-01-04
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2017-08-07
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2013-01-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2026-05-12
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-05-12
OOK	Dermal Cooling Pack/Vacuum/Massager	General, Plastic Surgery	Class 2	878.4340	2026-01-06
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Albert Wai-Kit Chan Business: Law Offices Of Albert Wai-Kit Chan Email: Chank@Kitchanlaw.Com Phone: (718) 7991000

Related Public Records

Same Entity

HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023281311	Automatic Enterprise (Thailand) Co., Ltd.	Rayong, TH
3008959444	HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.	Shek Mun, Shatin, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020978007. Last updated year: 2026. Please use registration number 3020978007 when referencing this establishment in official correspondence.