Data / Medical devices / United States / Oricle Hearing LLC
Oricle Hearing LLC: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Oricle Hearing LLC is registered with the FDA (registration 3027202846) in San Diego, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2023. Registered through 2026. 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
- 3027202846
- Address
- 2400 Kettner Blvd Ste 238, San Diego, CA, United States, 92101
- Owner or operator
- Lifetime Well LLC (10093120)
- Roles
- Manufacturer
- First device listed
- April 1, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 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 25, 2023 | K221052 | Self-Fitting hearing aids | QUH | Substantially Equivalent | Huizhou Jinghao Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 25, 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.