Data / Medical devices / China / Danyang Sunco Machinery Co., Ltd.
Danyang Sunco Machinery Co., Ltd.: FDA-registered device maker in Danyang City Jiangsu, China, 1 510(k) clearance
Danyang Sunco Machinery Co., Ltd. is registered with the FDA (registration 3011687503) in Danyang City Jiangsu, China. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 20, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011687503
- Address
- Taojing Road,Optics Industry Park, Situ, Danyang City Jiangsu, China, 212300
- Owner or operator
- DANYANG SUNCO MACHINERY CO., LTD. (10049225)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 30, 2015
- Registered through
- 2026
- Brand names listed
- AC-powered adjustable hospital bed, Alternating Pressure Air Flotation Mattress, Cane, Chair With Casters, Commode Chair, Crutch, Manual adjustable hospital bed, Nonpowered Flotation Therapy Mattress and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Attachment, Commode, Wheelchair | INB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bed, Manual | FNJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cane | IPS | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 20, 2016 | K153328 | SUNCO Mechanical Wheelchair, model SKW-9003 | IOR | Substantially Equivalent | Danyang Sunco Machinery Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Components, Wheelchair
- All makers of Bed, Manual
- All makers of Accessories, Wheelchair
- All makers of Cane
- All makers of Mattress, Flotation Therapy, Non-Powered
- All makers of Walker, Mechanical
Updated July 20, 2016. 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.