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510(k) K250096

Felix NeuroAI System by Fasikl Incorporated — Product Code QBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2025
Date Received
January 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Upper Limb Tremor Stimulator
Device Class
Class II
Regulation Number
882.5897
Review Panel
NE
Submission Type

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.

Other clearances for product code QBC

  • K251517 — Encora X1 (February 5, 2026)
  • K243848 — Cala kIQ (January 16, 2025)
  • K242259 — Cala kIQ (November 22, 2024)
  • K222237 — Cala kIQ (November 22, 2022)
  • K203288 — Cala Trio (October 5, 2021)
  • K182706 — External upper limb tremor stimulator (October 25, 2018)
  • DEN170028 — Cala ONE (April 26, 2018)