Neurology · 510(k) · 2025
Felix NeuroAI System
Fasikl Incorporated. Cleared by FDA on 1 July 2025 under submission K250096, product code QBC (external upper limb tremor stimulator). What FDA's record says, in FDA's words.
Device record · K250096
- Device. Felix NeuroAI SystemDEVICE
- Company. Fasikl IncorporatedCOMPANY
- Decision. 1 July 2025, 510(k), substantially equivalent (traditional review); received 14 January 2025DECISION
- Panel. NeurologyPANEL
- Product code. QBC, External Upper Limb Tremor StimulatorCODE
- Regulation. 21 CFR 882.5897, Class IIREG
- Source. FDA database entry · decision document (32 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Comparison The subject device and the predicate have the same intended use. Specifically, both devices are for transcutaneous stimulation for upper limb tremor related symptoms in essential tremor patients. The differences in indications for use are discussed in the table below and do not raise new questions of safety and effectiveness. Clinical data has been provided to support the modified indications for use. 8.2. Technological Characteristics The subject device has similar technological characteristics and principles of operation as the predicate device. Both devices deliver electrical stimulation to the wrist. Both have a stimulator with on-board motion sensors that detach from the connecting band, in addition to electrodes embedded in the band that produce biphasic rectangular waveforms with a similar phase and pulse durations. In addition, both devices have embedded firmware that allow for control of device calibration, stimulation delivery, and measurement of tremors. Both devices are also provided non-sterile. While there are some differences between the two devices in terms of technology (e.g. user interface, stimulation features, closed loop technology, as well as the energy source and device design), these differences do not raise new questions of safety and effectiveness. The differences in stimulation are shown not to impact safety or effectiveness of the device as determined by clinical evidence. Table 8.2 below provides technical comparison of the subject […]
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 6 reports filed against devices carrying product code QBC. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
1 April 2026 · Injury · CALA KIQ · CALA HEALTH INC · report 3011628389-2026-00001
THE PATIENT REPORTED THAT APPROXIMATELY 30 MINUTES INTO A THERAPY SESSION, HE WENT INTO ATRIAL FIBRILLATION (AFIB). HE BEGAN TO FEEL CHEST DISCOMFORT FOLLOWED BY DIZZINESS AND DIFFICULTY WALKING, WHICH LED HIM TO DISCONTINUE THE SESSION. THE PATIENT STATED HE OBSERVED A RESTING HEART RATE OF 125 BPM AND "VERY HIGH" BLOOD PRESSURE.THE PATIENT CONSULTED A CARDIOLOGIST THE NEXT DAY, AND WAS PRESCRIBED A 14-DAY CARDIAC MONITOR FOR A SUSPECTED EPISODE OF ATRIAL FIBRILLATION (AFIB). CALA IS […]
18 June 2025 · Injury · CALA KIQ · CALA HEALTH INC · report 3011628389-2025-00001
A HEALTHCARE PROVIDER'S OFFICE REPORTED THAT A PATIENT WAS HOSPITALIZED WITH AFIB REQUIRING A CARDIOVERSION AFTER USING THE DEVICE. THE PATIENT STOPPED USING THE DEVICE DUE TO THIS ISSUE. THE PATIENT'S SPOUSE REPORTED A HISTORY OF AFIB AND UNCERTAINTY ABOUT WHETHER THE RECENT EPISODE WAS CAUSED BY DEVICE USAGE. INITIALLY, THE PATIENT USED THE DEVICE REGULARLY WITHOUT ISSUE AND WISHED TO CONTINUE USE DUE TO FAVORABLE RESULTS WITH THE THERAPY, PENDING THE HEALTHCARE PROVIDER'S RECOMMENDATION. […]
23 December 2024 · Injury · CALA KIQ · CALA HEALTH · report 3011628389-2024-00002
A PATIENT REPORTED CONCERNS THAT THE CALA DEVICE MAY HAVE CONTRIBUTED TO A HEART-RELATED HEALTH EVENT. THE PATIENT EXPERIENCED CHEST PAIN WHILE USING THE DEVICE AND SPECULATED ABOUT A POSSIBLE CARDIAC EVENT, DESCRIBING A "SILENT BUT DEADLY HEART ATTACK," THOUGH HE ACKNOWLEDGED THIS MIGHT BE COINCIDENTAL. THE PATIENT ALSO NOTED HAVING A "DEAD LEFT VENTRICLE." THE PATIENT'S WIFE REPORTED THAT THE DEVICE WAS USED CONSISTENTLY FROM THE END OF (B)(6) 2023 TO BEGINNING OF (B)(6) 2024 AND THE PATIENT […]
11 April 2023 · Injury · CALA TRIO · CALA HEALTH, INC. · report MW5116561
(B)(6) HAS ESSENTIAL TREMOR, RIGHT HAND. IN CONFERENCE WITH HIS NURSE PRACTITIONER, THEY DECIDED TO TRY THE CALA TRIO, AN ELEC. STIMULATION WRISTBAND. HE USED IT FRIDAY 1 SESSION OF 40 MI, SATURDAY 1 SESSION OF 40 MIN. SUNDAY MORNING HE WOKE UP FEELING "DISCOMBOBULATED:, WITHIN 90 MIN OF WAKING, HE FADED OUT, ARMS LIMP, NON RESPONSIVE, MAY HAVE BEEN UNCONSCIOUS. FINALLY WOKE HIM , HE WAS CONFUSED, CALLED 911 AT 10:15 AM. AT HOSP FAST IRREGULAR HEARTBEAT. 120-150 RATE. 11:30 A.M. HEART WENT […]
2 May 2022 · Injury · CALA TRIO · CALA HEALTH, INC. · report MW5109481
BILATERAL HAND SWELLING. FDA SAFETY REPORT ID# (B)(4).
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QBC, in Neurology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.