Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016707048

FEI Number

3016707048

Entity Name

SHENZHEN RUIANKANG TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Floor 1 and 2, No. 8, Zhugushi Chunyang Industrial Park, Wulian Community, Longgang Street, Longgang District, Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Ruiankang Technology Co., Ltd. (Owner Number: 10090962)

Owner / Operator Contact Address

Floor 1 and 2, No. 8, Zhugushi Chunyang Industrial Park, Wulian Community, Longgang Street, Longgang District, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242528

PMA Number

N/A

All Registered Proprietary Names

Blood Pressure Monitor, models RAK260L, RAK261L, RAK262L, RAK263L, RAK266L, RAK268L, RAK269L Blood Pressure Monitor, models RAK268T, RAK283T, RAK288T, RAK289T, P100, RAK288G, RAK289G, P108 Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269) Blood Pressure Monitor (RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) Blood Pressure Monitor, models RAK290L, RAK291L, RAK292L, RAK293L, RAK295L, RAK296L, RAK297L, RAK298L, RAK299L Blood Pressure Monitor, models RAK280L, RAK281L, RAK282L, RAK283L, RAK285L, RAK286L, RAK288L, RAK289L Blood Pressure Monitor, models RAK261, RAK281, RAK285, RAK290, RAK299 Blood Pressure Monitor (RAK282, RAK283, RAK286, RAK288, RAK289) Blood Pressure Monitor, models P116, P126, P136, SK10, P608, RAK288A, RAK289A, RAK289B, P288

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	2025-02-28

Official Correspondent

Jinzhi Song

US Agent Details

Roy Zhang Business: RGLM Consulting LLC Email: admin@rglm-fda.com Phone: (425) 2364274

Related Public Records

Same Entity

Shenzhen Ruiankang 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 3016707048. Last updated year: 2026. Please use registration number 3016707048 when referencing this establishment in official correspondence.