Felix NeuroAI System

The Felix NeuroAI Wristband is a wrist-worn, non-invasive transcutaneous electrical neuromodulation device intended to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor. It continuously monitors tremor frequency and amplitude using built-in motion sensors and automatically adjusts stimulation settings via an AI algorithm, delivering electrical pulses to peripheral nerves in the wrist through disposable electrode bands.

Both the Felix and predicate (Cala Trio) deliver transcutaneous wrist stimulation with detachable stimulators containing motion sensors and electrodes producing biphasic rectangular waveforms. Key differences include: Felix has 3 stimulation channels (targeting radial, median, and ulnar nerves) versus Cala's 2 channels; Felix features AI closed-loop control and continuous monitoring whereas Cala is on-demand only; Felix uses a smartphone app and wireless USB charging versus Cala's device display and AC base station; Felix has higher maximum output current (10 mA) and voltage (5V) compared to Cala (8 mA, 4V); and electrode bands differ in size, number (4 vs. 3), and replacement frequency (daily vs. 90 days).

IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC for medical devices); IEC 60601-1-11 (home healthcare environment); IEC 60601-2-10 (nerve and muscle stimulators); IEC 60601-1-10 (physiologic closed-loop controllers); IEC 62133-2 (lithium battery safety); IEEE/ANSI USEMCSC C63.27-2021 (wireless coexistence); ISO 10993-1 (biocompatibility); and AAMI/ANSI ES 60601-1 (electrical safety for charger).

Although the Felix has technological differences from the Cala Trio predicate—including an additional stimulation channel, AI-driven closed-loop control, smartphone app interface, and modified electrical parameters—the applicant argues these do not raise new questions of safety or effectiveness because: (1) both devices use the same fundamental principle (transcutaneous wrist nerve stimulation for tremor relief); (2) non-clinical testing (software verification, bench testing, biocompatibility, electrical safety) demonstrates the design changes are safe; and (3) a prospective, randomized, sham-controlled clinical trial (TRANQUIL study) with 125 subjects showed Felix was superior to sham on the primary endpoint (change in TETRAS mADL score, p<0.0001) with an acceptable adverse event profile dominated by mild, self-limiting skin irritation, supporting safety and effectiveness for the modified indication of aiding tremor-related functional limitations while worn.