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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 K243613
Device Name Patch-TEA (Model TRI-21)
Applicant
Transtimulation Research, Inc.
800 Research Pkwy., # 337
Oklahoma City,  OK  73104
Applicant Contact Victor Pikov
Correspondent
Transtimulation Research, Inc.
800 Research Pkwy., # 337
Oklahoma City,  OK  73104
Correspondent Contact Victor Pikov
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/22/2024
Decision Date 04/09/2025
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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