Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012840029

FEI Number

3012840029

Entity Name

ETEKCITY CORPORATION

City/State/Country

Anaheim, CA, US

Establishment Address

1202 N Miller St Suite A, Anaheim, CA 92806, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

VESYNC (US) CORPORATION (Owner Number: 10053778)

Owner / Operator Contact Address

1775 Flight Way, Suite 150, Tustin, CA 92782, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180435

PMA Number

N/A

All Registered Proprietary Names

Upper Arm Blood Pressure Monitor, EBP-UA5 K5 Pro Etekcity TENS Unit ETU-134 Oral Irrigation - ETEKCITY Water Flosser, EWF-32 ETEKCITY TENS Unit Electrodes, ETU-P12 EFS-C651-KUS,EFS-C651-KJP, EFS-C651-KDE, EFS-C651-KUK, EFS-C651-XXXX EFS-E661-WUS,EFS-E661-KUS,EFS-E661-PUS,EFS-E661-XXXX,EFS-C671-WUST,EFS-C671-WUS EFS-A591S-KUS,EFS-A591S-KUSR,EFS-A591S-WUSR,EFS-A591S-KUST,EFS-A591S-WUST,EFS-A591S-XXXX Etekcity Fitness Scale, ESF93, FIT 8S,ESF00, ESF00+,ESF17, ESF18, ESF24, ESF28, ESF37, ESF14, ESF38,ESF-551 System, Measurement, Blood-Pressure, Non-Invasive - Etekcity Smart Blood Pressure Monitor, TMB-1583-BS, TMB-1583-BS-RXW Etekcity Non-Contact Infrared Body Thermometer, HTD8816C JXB-182 Non-contact Infrared Thermometer Etekcity Massager, EM-SH7, EM-SH7W, EM-SN8, EM-SN8W, EM-SN8S Scalp mini 2 S1336HA EM-SF3 Neck Massager Heated Pro,ENM-C221-WUS,ENM-C221-AUS Etekcity Upper Arm Blood Pressure Monitor, EBP-UA5

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
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-04-18
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2019-04-16
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2019-04-16
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2023-01-13
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-09-11
PUH	Analyzer, Body Composition, Exempt	Cardiovascular	Class 2	870.2770	2019-09-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-09-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-06-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-07-26
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2017-01-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-05-13

Official Correspondent

Arthur Sun

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VESYNC (US) CORPORATION

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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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 3012840029. Last updated year: 2026. Please use registration number 3012840029 when referencing this establishment in official correspondence.