Data / Medical devices / United States / WhisperMed LLC
WhisperMed LLC: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
WhisperMed LLC is registered with the FDA (registration 3038871368) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038871368
- Address
- 18207 Mcdurmott E Ste A, Irvine, CA, United States, 92614
- Owner or operator
- WhisperMed LLC (10093531)
- Roles
- Repackager or relabeler
- First device listed
- December 16, 2025
- Registered through
- 2026
- Brand names listed
- JuvPen MD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 7, 2025 | K243143 | E-PEN (E-PEN) | QAI | Substantially Equivalent | Bomtech Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 7, 2025. 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.