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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K253536
Device Name Evala Nerve Stimulator (EPNR002)
Applicant
Epineuron Technologies, Inc.
1875 Buckhorn Gate
Unit 602
Mississauga,  CA L4W5P1
Applicant Contact Mike Willand
Correspondent
Epineuron Technologies, Inc.
1875 Buckhorn Gate
Unit 602
Mississauga,  CA L4W5P1
Correspondent Contact Mike Willand
Regulation Number874.1820
Classification Product Code
ETN  
Date Received11/13/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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