Data / Medical devices / China / Shenzhen Yuwen E-Commerce Co., Ltd.
Shenzhen Yuwen E-Commerce Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 10 510(k) clearances
Shenzhen Yuwen E-Commerce Co., Ltd. is registered with the FDA (registration 3013957847) in Shenzhen Guangdong, China. It lists 19 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 28, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013957847
- Address
- 703 Room,7F, No.153, Zhonghuicai Building Donghuan 1th Rd., Longhua Street, Longhua new District, Shenzhen Guangdong, China, 518109
- Owner or operator
- Shenzhen Yuwen E-Commerce Co., Ltd. (10055812)
- Roles
- Exporter to the US, Foreign private label distributor, Repackager or relabeler
- First device listed
- July 12, 2018
- Registered through
- 2026
- Brand names listed
- AUVON Pressure relief wheelchair cushion, model SW6321, AUVON, Adhesive Electrodes, model EB1520, AUVON, Adhesive Electrodes, model EB1548, AUVON, Adhesive Electrodes, model EP3M12, AUVON, Anti-Slip Wheelchair Cushions, model SW4111, AUVON, BLOOD GLUCOSE MONITORING SYSTEM, model DS-W, AUVON, BLOOD GLUCOSE TEST STRIPS & STERILE LANCETS, model DS-W, AUVON, BLOOD GLUCOSE TEST STRIPS, model DS-W and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adult Portable Bed Rails For Medical Purposes | QTC | 1 | Exporter to the US | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Cushion, Hemorrhoid | LRL | U | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Foreign private label distributor | accessdata.fda.gov |
| Insulin Vial Protector/Holder | OJL | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Exporter to the US, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Foreign private label distributor | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Pill Crusher/Cutter | OHY | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Foreign private label distributor | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Foreign private label distributor | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| August 28, 2025 | K251429 | OTC 4-Channel Rechargeable TENS Unit | NUH | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 30, 2025 | K251706 | TENS and EMS Unit | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 11, 2025 | K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | NUH | Substantially Equivalent | Shenzhen Jiantuo Electronics Co., Ltd. | accessdata.fda.gov |
| May 9, 2025 | K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | NUH | Substantially Equivalent | Shenzhen Jiantuo Electronics Co., Ltd. | accessdata.fda.gov |
| March 12, 2025 | K243763 | Wireless TENS & EMS Unit | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| February 10, 2025 | K243511 | OTC TENS & EMS Unit | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 18, 2024 | K242787 | Tens & Ems Device (TU1080) | NGX | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 4, 2024 | K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | NUH | Substantially Equivalent | Changsha Anxiang Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 13, 2022 | K222770 | Conductive Gel | GYB | Substantially Equivalent | Top-Rank Health Care Co., Ltd. | accessdata.fda.gov |
| August 11, 2016 | K160138 | Adhesive Electrodes | GXY | Substantially Equivalent | Gmdasz Manufacturing Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Cushion, Wheelchair
- All makers of Component, Traction, Non-Invasive
- All makers of Electrode, Cutaneous
- All makers of Adult Portable Bed Rails For Medical Purposes
Updated August 28, 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.