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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 K182120
Device Name Maxpower Relief
Applicant
Omron Healthcare, Inc.
1925 West Field Court
Lake Forest,  IL  60045
Applicant Contact Renee Thornborough
Correspondent
Omron Healthcare, Inc. c/o ProMedic, LLC.
131 Bay Point Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received08/06/2018
Decision Date 01/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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