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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 K200803
Device Name BEAR and BEAR mini
Applicant
Foreo, Inc.
1525 E Pama Ln.
Las Vegas,  NV  89119
Applicant Contact Laura HoShue
Correspondent
Foreo, Inc.
1525 E Pama Ln.
Las Vegas,  NV  89119
Correspondent Contact Laura HoShue
Regulation Number882.5890
Classification Product Code
NFO  
Date Received03/27/2020
Decision Date 07/31/2020
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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