Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009445917

FEI Number

3009293069

Entity Name

NEURAXIS, INC

City/State/Country

Carmel, IN, US

Establishment Address

11611 N Meridian St, Suite 330, Carmel, IN 46032, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

NeurAxis, Inc (Owner Number: 10078247)

Owner / Operator Contact Address

11611 N Meridian St, Suite 330, Carmel, IN 46032, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252024

PMA Number

N/A

All Registered Proprietary Names

NeuroStim RED IB-Stim

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2020-10-15
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2024-12-30
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2024-12-30
QHH	Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)	Gastroenterology, Urology	Class 2	876.5340	2025-12-03

Official Correspondent

Thomas Carrico

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeurAxis, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009445917. Last updated year: 2026. Please use registration number 3009445917 when referencing this establishment in official correspondence.