Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013957847

FEI Number

3013957847

Entity Name

SHENZHEN YUWEN E-COMMERCE CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

703 Room,7F, No.153, Zhonghuicai Building, Donghuan 1th Rd., Longhua Street, Longhua new District, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device

Owner / Operator

Shenzhen Yuwen E-Commerce Co., Ltd. (Owner Number: 10055812)

Owner / Operator Contact Address

703 Room,7F, No.153, Zhonghuicai Building, Donghuan 1th Rd., Longhua Street, Longhua new District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222770

PMA Number

N/A

All Registered Proprietary Names

AUVON, Gel seat cushion, model SO7682 AUVON, Multi-layer Gel Cushion, model SO7632 AUVON, Innovative Donut Pillow, model SH2162 AUVON, Hemorrhoid Cushion, model SH3172 AUVON, Hemorrhoid Cushion, model SH5132 AUVON, Cool Donut Pillow, model SH2632 AUVON, Seat Cushion, model SO7732 AUVON, OTC 4-Channel Rechargeable TENS Unit, model TP2408C AUVON, SILICONE FOAM DRESSING, model SAS0407, SAS0412, SAS0422 AUVON, Silicone Foam Dressing, model SAS0322 AUVON, SACRUM SILICONE FOAM DRESSING, model SAH0705, SAH0710 AUVON, Silicone Foam Dressing, model SAS0603 AUVON, Silicone Foam Dressing, model SAS0310 AUVON, Pill Organizer, model PO0907 AUVON, Pill Organizer, model PO7807 AUVON, Pill Organizer, model PD4007 AUVON, Pill Organizer, model PO1807 Pill Organizer AUVON, Pill Organizer, model PO6814 AUVON, Pill Organizer, model PO6008 AUVON, Pill Dispenser, model PD4001 AUVON, Pill Organizer, model PD4006 Pill Dispenser AUVON, Pill Dispenser, model PD4000 AUVON, Bedrails, model MB1121 AUVON, TENS and EMS Unit, model TC3241 AUVON, Inflatable Neck Stretcher, model NI3663 AUVON, TENS AND EMS (TENS and Muscle Stimulator), model JT8016 AUVON, TENS AND EMS (TENS and Muscle Stimulator), model JT8012C AUVON,BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W AUVON, Lancing Device & Twist Lancets AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W AUVON, STERILE LANCETS AUVON, Wireless TENS & EMS Unit, model TX6224 AUVON, Insulin Pen Cooler Travel Case, model BO3213 AUVON, Insulin Pen Cooler Travel Case, model BO1341 AUVON, Insulin Pen Cooler Travel Case, model BO2120 AUVON, Insulin Pen Cooler Travel Case, model BO1120 AUVON, Insulin Pen Cooler Travel Case, model BO3313 AUVON, Insulin Pen Cooler Travel Case, model BO1221 AUVON, Clear Adhesive Waterproof Hydrogel Dressing, model SAS0410 AUVON, Clear Adhesive Waterproof Hydrogel Dressing, model SAS0403 AUVON, Muscle and Nerve Stimulator TENS & EMS, model TP2208 AUVON, Muscle and Nerve Stimulator TENS & EMS, model TP2208C AUVON, Adhesive Electrodes, model EB1520 AUVON, Adhesive Electrodes, model EP3M12 AUVON, Adhesive Electrodes, model EB1548 AUVON, lumbar pillow, model WO2121 AUVON, Pill Splitter, model PS1111 AUVON, Conductive Gel, model CG2252

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-09-26
LRL	Cushion, Hemorrhoid	Unknown	Class U	N/A	2024-12-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-09-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-09-15
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-10-31
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2018-07-12
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2024-01-22
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-09-05
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-09-05
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2026-01-14
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-05-29
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-05-29
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-09-26
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-09-26
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-03-27
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-03-27
OJL	Insulin Vial Protector/Holder	Physical Medicine	Class 1	890.5050	2025-07-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-06-09
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-01-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-01-21
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-04-01
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-06-30
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2018-12-28
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2023-09-07

Official Correspondent

Junyuan Chen

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

Shenzhen Yuwen E-Commerce 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01

Similar Registrations

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3010364377	Flexor SA	Barbera del Valles Barcelona, ES
3016232365	SHENZHEN FOAMTECH CO., LTD	Shenzhen Guangdong, CN
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013957847. Last updated year: 2026. Please use registration number 3013957847 when referencing this establishment in official correspondence.