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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 K260453
Device Name Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
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 Received02/11/2026
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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