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FDA 510(k)

NeurAxis IB-Stim (01-1020)

K-Number: K252024 · 2025-10-16

ApplicantNeuraxis
Decision Date2025-10-16
Product CodeQHH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NeurAxis IB-Stim (01-1020) is a medical device manufactured by Neuraxis. It received FDA 510(k) clearance on 2025-10-16 under approval number K252024. The device is classified under product code QHH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeurAxis IB-Stim (01-1020)?

NeurAxis IB-Stim (01-1020) is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Neuraxis. The 510(k) number is K252024.

When was NeurAxis IB-Stim (01-1020) approved by the FDA?

NeurAxis IB-Stim (01-1020) received FDA 510(k) clearance on 2025-10-16, under approval number K252024.

What company makes NeurAxis IB-Stim (01-1020)?

NeurAxis IB-Stim (01-1020) is manufactured by Neuraxis.

What is the FDA product code for NeurAxis IB-Stim (01-1020)?

The FDA product code for NeurAxis IB-Stim (01-1020) is QHH.

Other Devices by Neuraxis

K241533NeurAxis IB-Stim (01-1020) K250451NeurAxis IB-Stim (01-1020)

Related Devices (Code: QHH)

DEN180057IB-StimInnovative Health Solutions (Ihs), Inc. K202940First Relief v1Dyansys, Inc. K230526TEA DeviceTranstimulation Research, Inc. K241533NeurAxis IB-Stim (01-1020)Neuraxis K250451NeurAxis IB-Stim (01-1020)Neuraxis

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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