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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K262755
Device Name Wave Electrode;Remote Wave Electrode
Applicant
Bionit Labs Srl
Via Cracovia 1
Soleto,  IT 73010
Applicant Contact Aventaggiato Matteo
Correspondent
Bionit Labs Srl
Via Cracovia 1
Soleto,  IT 73010
Correspondent Contact Aventaggiato Matteo
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received08/03/2026
Decision Date 11/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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