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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, For Pain Relief
510(k) Number K061799
Device Name QUADRATENS, MODEL QT-42
Applicant
Bio-Research Associates, Inc.
9275 N. 49th St.
Suite 150
Brown Deer,  WI  53223
Applicant Contact JOHN C RADKE
Correspondent
Bio-Research Associates, Inc.
9275 N. 49th St.
Suite 150
Brown Deer,  WI  53223
Correspondent Contact JOHN C RADKE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/26/2006
Decision Date 08/28/2006
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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