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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Acupressure
510(k) Number K110563
Device Name PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
Applicant
Therapeutics 101, Inc (Dba Pressure Point, Inc.)
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact JULIE POWELL
Correspondent
Therapeutics 101, Inc (Dba Pressure Point, Inc.)
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact JULIE POWELL
Classification Product Code
MVV  
Date Received02/28/2011
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT01317082
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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