Cleared Traditional

K250096 - Felix NeuroAI System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K250096 · Fasikl Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
168d
Days
Class 2
Risk

K250096 is an FDA 510(k) clearance for the Felix NeuroAI System. Classified as External Upper Limb Tremor Stimulator (product code QBC), Class II - Special Controls.

Submitted by Fasikl Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 1, 2025 after a review of 168 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5897 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fasikl Incorporated devices

Submission Details

510(k) Number K250096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 148d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QBC External Upper Limb Tremor Stimulator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06235190 Active not recruiting Interventional Industry-sponsored

Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor

Assessment of a Novel NeuroAI-powered Transcutaneous Neuromodulation Device in Alleviating Tremor Symptoms and Enhancing Quality of Life for Patients with Upper Limb Essential Tremor

126
Patients (actual)
12
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Essential Tremor
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor Fasikl Inc. (industry)
Started 2024-02-27 → Primary completion 2024-10-31 → Completed 2025-11-01
Primary outcome
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90
Secondary outcome
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to 14 days, 30 days, 60 days, 180 days, and 1 year
View full study on ClinicalTrials.gov