FDA 510(k)

Felix NeuroAI System

K-Number: K250096 · 2025-07-01

Decision Date2025-07-01

Product CodeQBC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Felix NeuroAI System is the device name listed in this FDA 510(k) record. The listed applicant is Fasikl Incorporated. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K250096. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Felix NeuroAI System?

Felix NeuroAI System is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Fasikl Incorporated. The 510(k) number is K250096.

When did Felix NeuroAI System receive FDA 510(k) clearance?

Felix NeuroAI System received FDA 510(k) clearance on 2025-07-01, under 510(k) number K250096.

Who is the listed applicant for Felix NeuroAI System?

The FDA 510(k) record lists Fasikl Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Felix NeuroAI System?

The FDA product code for Felix NeuroAI System is QBC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06235190Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential TremorCOMPLETED NCT05842434Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's TremorCOMPLETED

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Official Source

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