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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 K061828
Device Name LORENZ BIOTECH APTIVA, VERSION 2.13
Applicant
Lorenz Biotech S.P.A.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
Lorenz Biotech S.P.A.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
HCC   IKN   JXE  
Date Received06/28/2006
Decision Date 08/24/2007
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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