Data / Medical devices / China / Danyang Huayi Medical Supply & Equipment Co, Ltd
Danyang Huayi Medical Supply & Equipment Co, Ltd: FDA-registered device maker in DANYANG Jiangsu, China, 5 510(k) clearances
Danyang Huayi Medical Supply & Equipment Co, Ltd is registered with the FDA (registration 3006534178) in DANYANG Jiangsu, China. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 4, 2009. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006534178
- Address
- No.1 Zhenxing RD, Yunyang Economical Development Zone, DANYANG Jiangsu, China, 212300
- Owner or operator
- Danyang Huayi Medical Supply & Equipment Co, Ltd. (9099959)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 4, 2007
- Registered through
- 2026
- Brand names listed
- Commode Chair, Knee walker, Overbed table, Portable Liquid Oxygen Unit Stand
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Commode, Wheelchair | INB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Geriatric | FRJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Manufacturer | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Exporter to the US | accessdata.fda.gov |
| Portable Liquid Oxygen Unit Stand | PCM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer | accessdata.fda.gov |
| Table, Mechanical | INW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | 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 |
|---|---|---|---|---|---|---|
| September 4, 2009 | K083559 | YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B | CAW | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
| July 6, 2009 | K091482 | HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 | IOR | Substantially Equivalent | Danyang Huayi Medical Supply & Equipment Co, Ltd. | accessdata.fda.gov |
| March 12, 2008 | K080207 | DANYANG HUAYI K2 AND K7 WHEELCHAIRS | IOR | Substantially Equivalent | Danyang Huayi Medical Supply & Equipment Co, Ltd. | accessdata.fda.gov |
| February 15, 2008 | K080114 | HUAYI H035 BASIC WHEELCHAIR | IOR | Substantially Equivalent | Danyang Huayi Medical Supply & Equipment Co, Ltd. | accessdata.fda.gov |
| October 11, 2000 | K002671 | EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR | IOR | Substantially Equivalent | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Chair, Adjustable, Mechanical
- All makers of Walker, Mechanical
- All makers of Wheelchair, Mechanical
- All makers of Attachment, Commode, Wheelchair
- All makers of Footrest, Wheelchair
Updated September 4, 2009. 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.