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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K262515
Device Name Kneu Platform (V2)
Applicant
Kneu Health Digital , Ltd.
Blackwell House, Guildhall Yard
London,  GB EC2V5AE
Applicant Contact Alessia Nannetti
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
ISD   NXQ  
Date Received07/21/2026
Decision Date 08/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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