Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014630021

FEI Number

3014630021

Entity Name

SHENZHEN YOLANDA TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 201, Jinfulai Building, No.49-1, Dabao Road, Dalang Area, Xinan Street, Baoan, Shenzhen, China, Room 101-501, 1-5 Floor, Building2, No. 8, Dongsheng Road, JiangHai District, JiangMen, Guangdong, China, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shenzhen Yolanda Technology Co., Ltd. (Owner Number: 10057904)

Owner / Operator Contact Address

Room 201, Jinfulai Building, No.49-1, Dabao Road, Dalang Area, Xinan Street, Baoan, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scale Upper Arm Blood Pressure Monitor, Model: SP10A,SP10B,SP10C,SP20A,SP20B,SP20C Massager gun, model of CM20C,CM20F Compact Percussion Massager, model of 239857 Upper Arm Blood Pressure Monitor,Model :SP10A,SP10B,SP10C,SP20A,SP20B,SP20C Body Composition Scale, model of ES-CS20M,ES-CS20M-W,ES-32MD,ES-26M,R-A019,R-A005 Body Composition Scale, model of CS20C,CS20A, CS20M,CS20N,CS20L,CS20G,CS20W,CS20F,CS20R,CS20P,Fit Plus LN,CS20T Body Composition Scale/Body Composition Analyzer,model of SCL-XBC200-BK, SCL-XBC200-WT, SCL-BBC200-BK,SCL-BBC200-WT Body Composition Scale, model of CS10K,CS10P,CS10G,CS10H,CS10E,CS10J Body Composition Scale/Body Composition Analyzer,model of SCL-BBC250-BK,SCL-BBC250-WT,SCL-BBC350-BK,SCL-BBC350-WT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2018-06-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-08-29
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-08-04
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-07-05
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2018-07-09

Official Correspondent

Lin Yao

US Agent Details

Anna. Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Shenzhen Yolanda 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

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3008386534	seca Medical Measuring Systems (pinghu) co. ltd.	Pinghu Zhejiang, CN
3012935929	A&D SCALES CO., LTD.	Jincheon-gun Chungbuk, KR
3012696053	HEALTHCHEK NETWORK, LLC	Lake Charles, LA, US
3011065399	Greater Goods, LLC	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014630021. Last updated year: 2026. Please use registration number 3014630021 when referencing this establishment in official correspondence.