Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022946813

FEI Number

3022946813

Entity Name

GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD

City/State/Country

Hanoi Ha Noi, VN

Establishment Address

Factory No. 6, Lot CN8, Thach That - Quoc Oai Industrial Park, Phung Xa Commune, Thach That District, Hanoi Ci, Hanoi Ha Noi 13100, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GIANTSUN POWER ELECTRONICS (VIETNAM) CO., LTD (Owner Number: 10089425)

Owner / Operator Contact Address

Factory No. 6, Lot CN8, Thach That - Quoc Oai Industrial Park, Phung Xa Commune, Thach That District, Hanoi Ci, Hanoi, VN-HN 13100, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iHealth (model: KN-550BT) iHealth (model: PO3)

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	2023-12-18
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2023-12-18

Official Correspondent

YAN NONG

US Agent Details

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

Related Public Records

Same Entity

GIANTSUN POWER ELECTRONICS (VIETNAM) 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 3022946813. Last updated year: 2026. Please use registration number 3022946813 when referencing this establishment in official correspondence.