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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 K131956
Device Name QUICK RELAX PRO
Applicant
Healthcare Innovations, LLC
28241 Crown Valley Pkwy., Suite 510(K)
Laguna Nuguel,  CA  92677
Applicant Contact SHEPARD G BENTLEY, RAC
Correspondent
Healthcare Innovations, LLC
28241 Crown Valley Pkwy., Suite 510(K)
Laguna Nuguel,  CA  92677
Correspondent Contact SHEPARD G BENTLEY, RAC
Regulation Number882.5890
Classification Product Code
NUH  
Date Received06/27/2013
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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