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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K251909
Device Name NeurotriS (SX2500); NeurotriS (SX3800)
Applicant
A-1 Engineering
30 Mauchly
Suite A
Irvine,  CA  92618
Applicant Contact Anthony Picciano
Correspondent
A-1 Engineering
30 Mauchly
Suite A
Irvine,  CA  92618
Correspondent Contact Anthony Picciano
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/20/2025
Decision Date 09/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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