NeurAxis IB-Stim (01-1020)
K-Number: K241533 · 2024-10-30
ApplicantNeuraxis
Decision Date2024-10-30
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 2024-10-30 under approval number K241533. 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 2024-10-30. It is manufactured by Neuraxis. The 510(k) number is K241533.
When was NeurAxis IB-Stim (01-1020) approved by the FDA?
NeurAxis IB-Stim (01-1020) received FDA 510(k) clearance on 2024-10-30, under approval number K241533.
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
Related Devices (Code: QHH)
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.