Felix NeuroAI System is an AI-enabled medical device from Fasikl Incorporated that the U.S. FDA cleared through 510(k) K250096 on July 1, 2025. Its lead review panel is Neurology and its primary product code is QBC (External Upper Limb Tremor Stimulator).
See also FDA-cleared AI neurology devices in 2025, all FDA AI clearances in 2025, top neurology AI devices.
Key facts
| Submission number | K250096 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Fasikl Incorporated |
| Lead review panel | Neurology |
| Primary product code | QBC — External Upper Limb Tremor Stimulator |
| Applicant (openFDA) | Fasikl Incorporated |
| Applicant location | Bloomington, MN, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 882.5897 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Felix NeuroAI System went through this pathway (K250096).
openFDA lists it as a Class 2 device under 21 CFR 882.5897. Class II devices are moderate risk and are subject to general and special controls.
Product code QBC covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Fasikl Incorporated has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.