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Shenzhen Huayan E-Commerce Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 12 510(k) clearances

Name: Shenzhen Huayan E-Commerce Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Huayan E-Commerce Co., Ltd. is registered with the FDA (registration 3017953405) in Shenzhen Guangdong, China. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated April 8, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017953405
Address: A2006, Rongde Times Square, Henggang Street, Longgang District, Shenzhen Guangdong, China, 518115
Owner or operator: Shenzhen Huayan E-commerce Co., Ltd. (10079753)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 21, 2020
Registered through: 2027
Brand names listed: Adhesive Electrode; Electrodes PADS, Belifu Conductive Gel, Blood Pressure Monitor MD3151, Fingertip Pulse Oximeter LK89, Fingertip Pulse Oximeter YM101, MKISCWEI 2 Face/face Evolution Skincare Device, Micro-current facial cold and hot service (Model:TPML-100), NEBULIZER, Model: CAN-B22394324, CAN-BEC-YK-N2, CAN-BEC-YK-N3, CAN-BC68003, CAN-BC68005, TZ-W13 and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Exporter to the US	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Contract manufacturer	accessdata.fda.gov
Media, Electroconductive	GYB	2	Exporter to the US	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US	accessdata.fda.gov
Oximeter, Wellness	PGJ	2	Exporter to the US	accessdata.fda.gov
Pulse Oximeter For Over-The-Counter Use	OLK	2	Exporter to the US	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Exporter to the US	accessdata.fda.gov
Stimulator, Transcutaneous Electrical, Aesthetic Purposes	NFO	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US	accessdata.fda.gov
Tube, Tonsil Suction	KCB	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 8, 2025	K243749	Jmoon Conductive Gel	GYB	Substantially Equivalent	Shenzhen Ulike Smart Electronics Co., Ltd.	accessdata.fda.gov
January 31, 2024	K214115	MightySat -OTC	OLK	Substantially Equivalent	Masimo Corporation	accessdata.fda.gov
May 25, 2022	K213039	Micro-current facial cold and hot service (model: TPML-100)	OLP	Substantially Equivalent	Li-Tek Electronics Technology C0., Ltd.	accessdata.fda.gov
April 1, 2022	K220005	TENS & PMS Unit	NUH	Substantially Equivalent	Shenzhen Yuehua Xinsen Technology Co., Ltd.	accessdata.fda.gov
May 19, 2021	K202866	TENS & EMS Device	NUH	Substantially Equivalent	Shenzhen Jian Feng Electronic Technology Co., Ltd.	accessdata.fda.gov
December 11, 2020	K201354	TENS & PMS	NGX	Substantially Equivalent	Hong Qiangxing (Shenzhen) Electronics Limited	accessdata.fda.gov
October 18, 2019	K191430	Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Yimi Life-Technology Co., Ltd.	accessdata.fda.gov
August 7, 2018	K181234	Self-adhesive Electrode	GXY	Substantially Equivalent	Dong Guan OU Kang Electronics Co., Ltd.	accessdata.fda.gov
August 11, 2016	K160138	Adhesive Electrodes	GXY	Substantially Equivalent	Gmdasz Manufacturing Co., Ltd.	accessdata.fda.gov
September 29, 2015	K152483	Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series	DXN	Substantially Equivalent	Grandway Technology (Shenzhen) Limited	accessdata.fda.gov
July 13, 2007	K063641	PC-60, NON-INVASIVEPULSE OXIMETER	DQA	Substantially Equivalent	Shenzhen Creative Industry Co., Ltd.	accessdata.fda.gov
July 16, 1992	K915075	NEBULIZER (DIRECT PATIENT INTERFACE)	CAF	Substantially Equivalent	Medi Nuclear Corp., Inc.	accessdata.fda.gov

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Updated April 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.