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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, Transcutaneous, Over-The-Counter
510(k) Number K243131
Device Name Triathlon Pro
Applicant
Sigma Biomedical
490 Sawgrass Corporate Pkwy.
Suite 130
Sunrise,  FL  33325
Applicant Contact Jorge Millan
Correspondent
Sigma Biomedical
490 Sawgrass Corporate Pkwy.
Suite 130
Sunrise,  FL  33325
Correspondent Contact Jorge Millan
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/30/2024
Decision Date 11/07/2025
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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