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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, For Pain Relief
510(k) Number K182025
Device Name ClearUP Sinus Pain Relief
Applicant
Tivic Health Systems, Inc.
750 Menlo Ave.
#200
Menlo Park,  CA  94025
Applicant Contact Nina Peled
Correspondent
Medical Device Regulatory Consultant
550 Davis St.
Unit 27
San Francisco,  CA  94111
Correspondent Contact Nina Peled
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NFO  
Date Received07/30/2018
Decision Date 01/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03466879
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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