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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 K260374
Device Name Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal
Applicant
Empatica S.r.l.
Via Enrico Stendhal, 36
Milan,  IT 20144
Applicant Contact Alberto Poli
Correspondent
Empatica S.r.l.
Via Enrico Stendhal, 36
Milan,  IT 20144
Correspondent Contact Alberto Poli
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
ISD   LEL   NXQ  
Date Received02/05/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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