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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, STE 510(K)
LAGUNA NIGUEL,  CA  92677
Applicant Contact SHEPARD G BENTLEY, RAC
Correspondent
HEALTHCARE INNOVATIONS, LLC
28241 CROWN VALLEY PKWY, STE 510(K)
LAGUNA NIGUEL,  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
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