Data / Medical devices / China / Weony (shenzhen) Technology Co., Ltd.
Weony (shenzhen) Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Weony (shenzhen) Technology Co., Ltd. is registered with the FDA (registration 3021247088) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021247088
- Address
- 401, the 6th building, Changfeng Industrial Zone, Dongkeng Community, Fenghuang Street Guangming District, Shenzhen Guangdong, China, 518132
- Owner or operator
- Weony (Shenzhen) Technology Co., Ltd. (10083229)
- Roles
- Manufacturer
- First device listed
- November 3, 2021
- Registered through
- 2026
- Brand names listed
- WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107, WBP108 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| September 7, 2023 | K231542 | Digital Blood Pressure Monitor WBP Series | DXN | Substantially Equivalent | Weony (Shenzhen) Technology Co., Ltd. | accessdata.fda.gov |
| August 13, 2021 | K210671 | Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 | DXN | Substantially Equivalent | Weony (Shenzhen) Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 7, 2023. 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.