Data / Medical devices / China / Huaian Youwen Medical Technology Co.,ltd
Huaian Youwen Medical Technology Co.,ltd: FDA-registered device maker in HUAIAN Jiangsu, China, 1 510(k) clearance
Huaian Youwen Medical Technology Co.,ltd is registered with the FDA (registration 3014542717) in HUAIAN Jiangsu, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2011. 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
- 3014542717
- Address
- Minbing Road, East Shuanggou Town, Hongze District, HUAIAN Jiangsu, China, 223121
- Owner or operator
- HUAIAN YOUWEN MEDICAL TECHNOLOGY CO.,LTD (10058861)
- Roles
- Manufacturer
- First device listed
- November 4, 2018
- Registered through
- 2026
- Brand names listed
- Anti-Bedsore Mattress, Hot&Cold / Therapy Pad , Hot&Cold / Water Therapy Wrap, Cold Therapy System, Hot&Cold/Therapy Pad, Hot&Cold/Water Therapy Wrap, Hot&Cold/Therapy Pad, Hot&Cold/Water Therapy Wrap, Cold Therapy System, Ice Bucket; Cold Therapy System, Sleeve, Limb, Compressible Garment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 9, 2011 | K110276 | POWERPRESS UNIT | JOW | Substantially Equivalent | Hanuri Distribution, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Massager, Powered Inflatable Tube
- All makers of Sleeve, Limb, Compressible
Updated November 9, 2011. 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.