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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
510(k) Number K230526
Device Name TEA Device
Applicant
Transtimulation Research, Inc.
800 Research Pkwy., Suite 337
Oklahoma City,  OK  73104
Applicant Contact Jieyun Yin
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
Suite 166
Needham,  MA  02492
Correspondent Contact Eric Bannon
Regulation Number876.5340
Classification Product Code
QHH  
Date Received02/27/2023
Decision Date 09/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05392439
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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