NeurAxis IB-Stim (01-1020)— 510(k) K252024

Substantially Equivalent

Neuraxis

FDA 510(k) clearance K252024 for NeurAxis IB-Stim (01-1020), Substantially Equivalent on 2025-10-16. Applicant: Neuraxis. Device class: 2.

Clearance details

Applicant: Neuraxis
Product code: Code QHH
Device class: Class 2
Regulation: 21 CFR 876.5340
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-30
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QHH

K250451 — NeurAxis IB-Stim (01-1020)2025-05-15
K241533 — NeurAxis IB-Stim (01-1020)2024-10-30
K230526 — TEA Device2023-09-14
K202940 — First Relief v12020-12-29
DEN180057 — IB-Stim2019-06-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.