Data / Medical devices / United States / Neuvotion, Inc.
Neuvotion, Inc.: FDA-registered device maker in Stamford, CT, United States, 1 510(k) clearance
Neuvotion, Inc. is registered with the FDA (registration 3046040683) in Stamford, CT, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3046040683
- Address
- 165 Club Rd, Stamford, CT, United States, 06905
- Owner or operator
- Neuvotion, Inc. (10096075)
- Roles
- Specification developer
- First device listed
- June 18, 2026
- Registered through
- 2026
- Brand names listed
- NeuStim
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 22, 2024 | K240632 | Neuvotion NeuStim NN-01 | GZI | Substantially Equivalent | Neuvotion, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Stimulator, Muscle, Powered
Updated November 22, 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.