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Felix NeuroAI

FDA UDI

Class II (US FDA UDI)

by Fasikl Incorporated

Identity

Trade Name
Felix NeuroAI FDA UDI
Generic Name
Tremor-suppression transcutaneous electrical stimulation wristband FDA UDI
Device Name
Electrode Band black EB1-M3 FDA UDI
Model / Reference
EB1-M3 FDA UDI
Description
Electrode Band black EB1-M3 FDA UDI

Identifiers

Primary DI / UDI-DI
00850077317132 FDA UDI
510(k) Number
K250096 FDA UDI
FDA Product Code
QBC FDA UDI
GMDN Term
Tremor-suppression transcutaneous electrical stimulation wristband FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5897 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Tremor-suppression transcutaneous electrical stimulation wristband

Felix NeuroAI by Fasikl Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tremor-suppression transcutaneous electrical stimulation wristband.

Cleared under the same submission

K250096 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fasikl Incorporated

Sources (1)

  • FDA UDI 1ae181a7-a93f-4675-9528-fd9c2f612287 34 fields · synced Jun 6, 2026