Data / Medical devices / China / Yiwu Thousand Shores E-Business Co., Ltd
Yiwu Thousand Shores E-Business Co., Ltd: FDA-registered device maker in Yiwu Zhejiang, China, 3 510(k) clearances
Yiwu Thousand Shores E-Business Co., Ltd is registered with the FDA (registration 3015214304) in Yiwu Zhejiang, China. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015214304
- Address
- 9th Floor, Block A, No. 512, Lianhua South Road, Choujiang Sub-district, Yiwu Zhejiang, China, 322000
- Owner or operator
- YIWU THOUSAND SHORES E-BUSINESS CO., LTD (10060132)
- Roles
- Exporter to the US
- First device listed
- April 2, 2019
- Registered through
- 2026
- Brand names listed
- Electric Body Massager, Electric Massage Belt, Electric Massage Cushion,, Electrical Stimulator, Guasha stone, Ice pack, Infrared Thermometer, Knee Support, Knee BraceST-0043 ,Knee Sleeve(SYK-1800), Palm Support, Palm Sleeve, Palm Brace,STK-1901, FF PRO KNEE OA, Lumbar Support, Y15-80100-42, MUSCLE ROLLER STICK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Ice | KYR | 1 | Exporter to the US | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Exporter to the US | accessdata.fda.gov |
| Cane | IPS | 1 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Exporter to the US | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | 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 |
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 |
|---|---|---|---|---|---|---|
| June 7, 2018 | K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | NUH | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| March 14, 2018 | K172795 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| July 21, 2015 | K143268 | TENS AND POWERED MUSCLE STIMULATOR | NUH | Substantially Equivalent | Shenzhen As-Tec Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Corrective Shoe
- All makers of Orthosis, Limb Brace
- All makers of Joint, Knee, External Brace
- All makers of Brush, Dermabrasion, Powered
- All makers of Bag, Ice
- All makers of Cane
Updated June 7, 2018. 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.