FDA.reportPublic FDA data

Felix NeuroAI

Primary DI
00850077317224
Brand
Felix NeuroAI
Company
Fasikl Incorporated
Model
CB1-S1
Published
2025-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QBCExternal Upper Limb Tremor Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBCExternal Upper Limb Tremor StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250096000Felix NeuroAI SystemFasikl Incorporated2025-07-01QBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077317224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077317224008500773172248500773172240850077317224

GMDN Terms#

Term, Definition table
TermDefinition
Tremor-suppression transcutaneous electrical stimulation wristbandAn electrically-powered device designed to be worn on the wrist of an adult patient with hand tremors [e.g., due to Parkinson’s disease, essential tremor (ET)] to: 1) collect motion data (e.g., tremor frequency); and 2) apply patient-specific electrical stimuli to the median and/or radial nerve(s) through the skin (transcutaneously) to help suppress or cancel the tremors. It is a wristwatch-like device that includes a motion sensor, pulse generator and electrodes; the technology may be referred to as transcutaneous afferent patterned stimulation (TAPS). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103758013
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077317002Felix NeuroAIC12025-08-13
00850077317019Felix NeuroAIS12025-08-13
00850077317026Felix NeuroAIS12025-08-13
00850077317033Felix NeuroAIS12025-08-13
00850077317040Felix NeuroAIS12025-08-13
00850077317118Felix NeuroAIEB1-L22025-08-13
00850077317125Felix NeuroAIEB1-L12025-08-13
00850077317132Felix NeuroAIEB1-M32025-08-13
00850077317149Felix NeuroAIEB1-M22025-08-13
00850077317156Felix NeuroAIEB1-M12025-08-13
00850077317163Felix NeuroAIEB1-S12025-08-13
00850077317170Felix NeuroAICB1-L22025-08-13
00850077317187Felix NeuroAICB1-L12025-08-13
00850077317194Felix NeuroAICB1-M32025-08-13
00850077317200Felix NeuroAICB1-M22025-08-13
00850077317217Felix NeuroAICB1-M12025-08-13
00850077317231Felix NeuroAIFELIX-G12025-08-13
00850077317248Felix NeuroAIFELIX-G12025-08-13
00850077317255Felix NeuroAIFELIX-G12025-08-13
00850077317262Felix NeuroAIFELIX-G12025-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851749007528Cala kIQ PlusCALA HEALTH, INC.QBC2026-05-01
00851749007535Cala kIQ PlusCALA HEALTH, INC.QBC2026-05-01
00851749007542Cala kIQCALA HEALTH, INC.QBC2026-05-01
00851749007559Cala kIQCALA HEALTH, INC.QBC2026-05-01
00851749007566Cala kIQ CALA HEALTH, INC.QBC2026-05-01
00850077317002Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317019Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317026Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317033Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317040Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317118Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317125Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317132Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317149Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317156Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317163Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317170Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317187Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317194Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317200Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317217Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317231Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317248Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317255Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00850077317262Felix NeuroAIFasikl IncorporatedQBC2025-08-13
00851749007474Cala kIQCALA HEALTH, INC.QBC2025-03-24
00851749007481Cala kIQCALA HEALTH, INC.QBC2025-03-24
00851749007498Cala kIQCALA HEALTH, INC.QBC2025-03-24
00851749007412Cala kIQCALA HEALTH, INC.QBC2023-06-12
00851749007429Cala kIQCALA HEALTH, INC.QBC2023-06-12