Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017887928

FEI Number

3017887928

Entity Name

ETEKCITY COMPANY LIMITED

City/State/Country

Macau, MO

Establishment Address

L 7/F, China Plaza, 762-804 Da Ma Road, South Bay,, Macau 999078, MO

Establishment Type(s)

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

Owner / Operator

ETEKCITY COMPANY LIMITED (Owner Number: 10079727)

Owner / Operator Contact Address

L 7/F, China Plaza, 762-804 Da Ma Road, South Bay,, Macau, MO-NOTA 999078, MO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Etekcity Smart Blood Pressure Monitor, TMB-1583-BS, TMB-1583-BS-RXW Etekcity Upper Arm Blood Pressure Monitor, EBP-UA5 Etekcity Massager, EM-SF3,S1336HA,Scalp mini 2,K5 Pro Etekcity Massager, EM-SH7, EM-SH7W, EM-SN8, EM-SN8W, EM-SN8S IRRIGATOR, POWERED NASAL ETB-C011-KUS ETB-C011-WUS ETB-C011-BUS ETB-C011-YUS ETB-C011-PUS ETB-C013-KUS ETB-C013-WUS ETB-C013-BUS ETB-C013-PUS ETB ETEKCITY TENS Unit Electrodes, ETU-P12 JXB-182 Non-contact Infrared Thermometer Etekcity Non-Contact Infrared Body Thermometer, HTD8816C Etekcity Smart Blood Pressure Monitor, TMB-1583-BS, TMB-1583-BS-RXW Etekcity Upper Arm Blood Pressure Monitor, EBP-UA5 EFS-A591S-KUS,EFS-A591S-KUSR,EFS-A591S-WUSR,EFS-A591S-KUST,EFS-A591S-WUST,EFS-A591SXXXX EFS-E661-WUS,EFS-E661-KUS,EFS-E661-PUS,EFS-E661-XXXX,EFS-C671-WUST,EFS-C671-WUS EFS-C651-KUS, EFS-C651-KJP, EFS-C651-KDE, EFS-C651-KUK, EFS-C651-XXXX Etekcity Fitness Scale, ESF93, FIT 8S, ESF00, ESF00+, ESF17, ESF18, ESF24, ESF28, ESF37, ESF14, ESF38, ESF-551

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	2023-01-15
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-05-20
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2023-01-13
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-10-27
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-05-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-12-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-05-20
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2021-05-10

Official Correspondent

Wayne Pan

US Agent Details

Wayne Pan Business: ATEKCITY CORPORATION Email: wayne.pan@vesync.com Phone: (515) 7822647

Related Public Records

Same Entity

ETEKCITY COMPANY 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 3017887928. Last updated year: 2026. Please use registration number 3017887928 when referencing this establishment in official correspondence.