Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003657019

FEI Number

3003657019

Entity Name

TRULY INSTRUMENT LIMITED

City/State/Country

KWAI CHUNG, HK

Establishment Address

2ND FLOOR, 1-3 WING YIP ST., KWAI CHUNG --, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TRULY INSTRUMENT LIMITED (Owner Number: 9054344)

Owner / Operator Contact Address

2ND FLOOR, 1-3 WING YIP ST., --, KWAI CHUNG, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081852

PMA Number

N/A

All Registered Proprietary Names

Blood Pressure Monitor Truly Truly Masters ReliaMed SureLife SAMICO Truly Andesfit Limited Truly Power Toothbrush Truly Truly TRULY Truly Automatic Blood Pressure Monitor PressurePlus Automatic Blood Pressure Monitor Infopia Automatic Blood Pressure Monitor SmartDiabetes Automatic Blood Pressure Monitor

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	2008-05-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-12-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-08-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-03-17
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-03-31
MMD	Toothbrush, Ionic, Battery-Powered	Dental	Class 1	872.6865	2002-12-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-05-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-05-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2009-12-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

Max Wong Business: Truly (U.S.A.) Inc. Email: maxwong@trulyusa.com Phone: (626) 2843033

Related Public Records

Same Entity

TRULY INSTRUMENT LIMITED

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 3003657019. Last updated year: 2026. Please use registration number 3003657019 when referencing this establishment in official correspondence.