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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 K183215
Device Name Focus TENS Therapy, Model PM710-M/-L
Applicant
Omron Healthcare, Inc.
1925 W. Field Court
Suite 100
Lake Forest,  IL  60045
Applicant Contact Renee Thornborough
Correspondent
Experien Group
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Ronald S. Warren
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/19/2018
Decision Date 09/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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