Data / Medical devices / United States / eNeura Inc
eNeura Inc: FDA-registered device maker in Baltimore, MD, United States, 1 510(k) clearance
eNeura Inc is registered with the FDA (registration 3008487930) in Baltimore, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008487930
- Address
- 101 West Dickman St. Suite 900, Baltimore, MD, United States, 21230
- Owner or operator
- eNeura Inc. (10039355)
- Roles
- Manufacturer
- First device listed
- November 2, 2023
- Registered through
- 2026
- Brand names listed
- eNeura Spring TMS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache | OKP | 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 |
|---|---|---|---|---|---|---|
| May 16, 2023 | K230358 | SAVI Dual (TM) Migraine Therapy | OKP | Substantially Equivalent | Eneura, Inc. | accessdata.fda.gov |
Updated May 16, 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.