NeurAxis IB-Stim (01-1020)— 510(k) K241533

Substantially Equivalent

Neuraxis

FDA 510(k) clearance K241533 for NeurAxis IB-Stim (01-1020), Substantially Equivalent on 2024-10-30. 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: 2024-05-30
Decision date: 2024-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QHH

K252024 — NeurAxis IB-Stim (01-1020)2025-10-16
K250451 — NeurAxis IB-Stim (01-1020)2025-05-15
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.