Data / Medical devices / United States / Jetema Usa
Jetema Usa: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Jetema Usa is registered with the FDA (registration 3044464950) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044464950
- Address
- 200 Spectrum Center Dr Ste 300, Irvine, CA, United States, 92618
- Owner or operator
- Jetema USA (10095394)
- Roles
- Repackager or relabeler
- First device listed
- July 7, 2026
- Registered through
- 2026
- Brand names listed
- REVAFLUX with RF Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| December 26, 2024 | K243097 | RM STAR EX with RMS Needle | GEI | Substantially Equivalent | Bomtech Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 26, 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.