Devices · Fasikl Incorporated

Felix NeuroAI System

Fasikl Incorporated is listed for Felix NeuroAI System (K250096). The FDA list gives July 1, 2025 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QBC as “External Upper Limb Tremor Stimulator”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250096

Official FDA database record

Date of final decision

July 1, 2025

Company on the FDA list

Fasikl Incorporated

Lead panel

Neurology

Primary product code

QBC

openFDA device name for the code

External Upper Limb Tremor Stimulator

Device class

2

Regulation number

882.5897

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary