# K250096: Felix NeuroAI  System

- Pathway: 510(k) (Traditional)
- Applicant: Fasikl Incorporated
- Decided: Jul 1, 2025 after 168 days
- Product code: QBC (External Upper Limb Tremor Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5897
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170028 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203288: Cala Trio, Cala Health, Inc. (2021) Summary page 5.

## Indications for use
The Felix™ NeuroAI™ Wristband is indicated to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor.

Source page: https://510kreport.com/device/K250096
Methodology: https://510kreport.com/methodology