Felix NeuroAI System

K250096

Fasikl Incorporated · cleared 2025-07-01 · product code QBC · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Fasikl's Felix™ NeuroAI™ Wristband is a wrist-worn, noninvasive, transcutaneous neurostimulation system. It is intended to be used by adult patients with essential tremor (ET) on a daily basis to aid in tremor-related functional limitations in the upper limbs. The system continuously monitors tremor frequency and tremor amplitude and automatically adjusts stimulation settings. The Felix system consists of the following components: Felix wristband (NeuroAI™ stimulator with integrated strap and detachable connector band), disposable electrode band, wireless charger, and smartphone application. The sole purpose of the AI algorithm is to control the stimulation state of the Felix device. It is NOT intended to be used for any diagnostic purposes and has no interpretable outputs. It automatically determines whether to turn stimulation on or off and at what stimulation intensity, based on measurements of the effects of stimulation on the severity of hand tremor (as assessed by the built-in accelerometer).”
AlgorithmAI algorithm that automatically determines whether to turn stimulation on or off and at what stimulation intensity, based on measurements of the effects of stimulation on the severity of hand tremor (as assessed by the built-in accelerometer).
source quote (p.7)
“The sole purpose of the AI algorithm is to control the stimulation state of the Felix device. It is NOT intended to be used for any diagnostic purposes and has no interpretable outputs. It automatically determines whether to turn stimulation on or off and at what stimulation intensity, based on measurements of the effects of stimulation on the severity of hand tremor (as assessed by the built-in accelerometer).”
Adaptive (vs locked)Yes
source quote (p.5)
“The system continuously monitors tremor frequency and tremor amplitude and automatically adjusts stimulation settings. In Artificial Intelligence (AI) closed-loop stimulation mode, the app will communicate with a secure cloud computing services for AI to determine the best stimulation setting for the user continuously and control the stimulator accordingly.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Cybersecurity testing was provided to support the use of Smartphone.”

Validation studies (2)

Prospective clinical

n=125 patients · 12 site(s)

endpoints: Change in TETRAS modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90, Superiority of Felix versus Sham stimulation.; Change in TETRAS mADL score from baseline pre-stimulation to 14 days, 30 days, and 60 days.; TETRAS Performance Subscale (items 1, 4 and 8) at baseline pre-stimulation, baseline post-stimulation, 30 days, 90 days; TETRAS Performance Subscale (items 6 and 7) at baseline pre-stimulation, baseline post-stimulation, 14 days, 30 days, 60 days, 90 days.; TETRAS Dominant Hand Score at baseline pre-stimulation, baseline post-stimulation, 30 days, 90 days. Defined as the total scores of TETRAS Performance Subscale for the dominant hand (items 4, 6, 7 and 8); Clinical Global Impression of Improvement (CGI-I) baseline post-stimulation, 30 days, 90 days; Patient Global Impression of Improvement (PGI-I) at baseline post-stimulation, 14 days, 30 days, 60 days, 90 days; Quality of Life in Essential Tremor Questionnaire (QUEST) at baseline pre-stimulation, 90 days; Adverse events (AEs) and serious adverse events (SAEs); Adverse device effects (ADEs) and serious adverse device effects (SADEs); Unanticipated adverse device effect (UADE) and unanticipated serious adverse device effect (USADE)

standards: IEC 60601-1-10 Edition 1.2 2020-07: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers., IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators, IEC 62133-2: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems, IEEE/ANSI USEMCSC C63.27-2021: American National Standard for Evaluation of Wireless Coexistence., International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Bench

sample size not stated

endpoints: Test the pulse width, amplitude, rising time, falling time, pulse interval, current adjustment step value, and charge balancing, and observe whether the waveform meets the design input requirements.; Verify that the adhesion and impedance performance of the Electrode band meets the requirements specified by FASIKL.; The objective of the test is to measure the current distribution on the surface of the gel electrodes for the Felix-G1 watch device; Test the accuracy of the vibration frequency and acceleration values recorded by the Felix device to meet the design requirements.

standards: IEC 60601-1-10 Edition 1.2 2020-07: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers., IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators, IEC 62133-2: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems, IEEE/ANSI USEMCSC C63.27-2021: American National Standard for Evaluation of Wireless Coexistence., International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
0%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250096