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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K251517
Device Name Encora Pulse
Applicant
Encora, Inc.
311 Summer St.
Boston,  MA  02210
Applicant Contact Allison Davanzo
Correspondent
Encora, Inc.
311 Summer St.
Boston,  MA  02210
Correspondent Contact Allison Davanzo
Date Received05/16/2025
Decision Date 02/05/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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