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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K212342
Device Name ZIIP+ Device
Applicant
Ziip, Inc.
1425 Leimert Blvd., Suite 202
Oakland,  CA  94062
Applicant Contact David Mason
Correspondent
Hill Regulatory Consulting, LLC
1910 15th Ave. E
Seattle,  WA  98112
Correspondent Contact Heather Tanner
Regulation Number882.5890
Classification Product Code
NFO  
Date Received07/28/2021
Decision Date 09/23/2021
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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