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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 K141978
Device Name MAXPOWER RELIEF
Applicant
OMRON HEALTHCARE, INC.
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
OMRON HEALTHCARE, INC.
24301 WOODSAGE DR.
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number882.5890
Classification Product Code
NUH  
Date Received07/21/2014
Decision Date 12/03/2014
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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