Data / Medical devices / China / Our United Corporation
Our United Corporation: FDA-registered device maker in Xian Shaanxi, China, 2 510(k) clearances
Our United Corporation is registered with the FDA (registration 3015620182) in Xian Shaanxi, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015620182
- Address
- Room 10301, 3rd Floor, Unit 1, Block 28, Shou Chuang International Business Center, NO. 66 Fengcheng 12 Road Xian Economic and Technological Development Zone, Shaanxi Province, Xian Shaanxi, China, 710018
- Owner or operator
- OUR United Corporation (10087551)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- March 14, 2023
- Registered through
- 2026
- Brand names listed
- CybeRay, Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System, TaiChiA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Radiation Therapy, Radionuclide | IWB | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 12, 2021 | K203250 | TaiChiC | IWB | Substantially Equivalent | Our United Corporation | accessdata.fda.gov |
| August 7, 2020 | K193207 | TaiChiA | IYE | Substantially Equivalent | Our United Corporation | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2021. 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.