Data / Medical devices / United States / Anriwell
Anriwell: FDA-registered device maker in Riverside, CA, United States, 4 510(k) clearances
Anriwell is registered with the FDA (registration 3043513123) in Riverside, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 1, 2024. Registered through 2027. 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
- 3043513123
- Address
- 9253 Dauchy Ave, Riverside, CA, United States, 92508
- Owner or operator
- Anriwell (10095154)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- January 29, 2026
- Registered through
- 2027
- Brand names listed
- AW-201, AW-301, AW-401, AW-501, Anriwell Breeze, Anriwell Breeze (OTC), Anriwell Gluco, Anriwell Pressia and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| July 1, 2024 | K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 14, 2023 | K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 20, 2020 | K191657 | Bioland Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| April 22, 2016 | K160019 | U80 Series Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Urion Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter, Wellness
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Continuous Measurement Thermometer
- All makers of Oximeter
Updated July 1, 2024. 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.