Data / Medical devices / United States / Neuraxis, Inc
Neuraxis, Inc: FDA-registered device maker in Carmel, IN, United States, 4 510(k) clearances
Neuraxis, Inc is registered with the FDA (registration 3009445917) in Carmel, IN, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009445917
- FEI number
- 3009293069
- Address
- 11611 N Meridian St Suite 330, Carmel, IN, United States, 46032
- Owner or operator
- NeurAxis, Inc (10078247)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 15, 2020
- Registered through
- 2026
- Brand names listed
- IB-Stim, NeuroStim, RED
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | QHH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 16, 2025 | K252024 | NeurAxis IB-Stim (01-1020) | QHH | Substantially Equivalent | Neuraxis | accessdata.fda.gov |
| December 6, 2024 | K242304 | RED | KLA | Substantially Equivalent | Neuraxis, Inc. | accessdata.fda.gov |
| June 7, 2019 | DEN180057 | IB-Stim | QHH | Unknown | Innovative Health Solutions (Ihs), Inc. | accessdata.fda.gov |
| October 2, 2014 | K140530 | Electro Auricular Device | BWK | Substantially Equivalent | Navigant Consulting, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Gastrointestinal Motility (Electrical)
- All makers of Monitor, Esophageal Motility, Anorectal Motility, And Tube
- All makers of Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
- All makers of Stimulator, Electro-Acupuncture
Updated October 16, 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.