Data / Medical devices / United States / Epsimed LLC
Epsimed LLC: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance
Epsimed LLC is registered with the FDA (registration 3009495681) in Miami, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 5, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009495681
- Address
- 13230 Sw 132nd Ave # B21, Miami, FL, United States, 33186
- Owner or operator
- EPSIMED LLC (10039670)
- Roles
- Repackager or relabeler
- First device listed
- March 26, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Peripheral, Electric | KOI | 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 |
|---|---|---|---|---|---|---|
| May 5, 2022 | K212434 | Neuromuscular Transmission Monitor TOF3D | KOI | Substantially Equivalent | MIPM Mammendorfer Institut für Physik und Medizin GmbH | accessdata.fda.gov |
Compare with other makers
Updated May 5, 2022. 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.