Cleared Traditional

Felix NeuroAI System

K250096 · Fasikl Incorporated · Neurology
Jul 2025
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K250096 is an FDA 510(k) clearance for the Felix NeuroAI System, a External Upper Limb Tremor Stimulator (Class II — Special Controls, product code QBC), submitted by Fasikl Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 1, 2025, 168 days after receiving the submission on January 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5897.

Submission Details

510(k) Number K250096 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2025
Decision Date July 01, 2025
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QBC — External Upper Limb Tremor Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5897
Definition An External Upper Limb Tremor Stimulator Is A Prescription Device Which Is Placed Externally On The Upper Limb And Designed To Aid In Tremor Symptom Relief Of The Upper Limb.