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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 K233095
Device Name S21 OTC Transcutaneous Electrical Nerve Stimulator
Applicant
Micro Current Technology, Inc.
2244 1st Ave. S.
Seattle,  WA  98134
Applicant Contact David Suzuki
Correspondent
Micro Current Technology, Inc.
2244 1st Ave. S.
Seattle,  WA  98134
Correspondent Contact David Suzuki
Regulation Number882.5890
Classification Product Code
NUH  
Date Received09/26/2023
Decision Date 03/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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