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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Upper Limb Tremor Stimulator
510(k) Number K250096
Device Name Felix NeuroAI System
Applicant
Fasikl Incorporated
8500 Normandale Lake Blvd., Suite 400
Bloomington,  MN  55437
Applicant Contact Zhen Zhang
Correspondent
Fasikl Incorporated
8500 Normandale Lake Blvd., Suite 400
Bloomington,  MN  55437
Correspondent Contact Zhen Zhang
Regulation Number882.5897
Classification Product Code
QBC  
Date Received01/14/2025
Decision Date 07/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT06235190
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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