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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 K083494
Device Name ULTIMA FIVE
Applicant
PAIN MANAGEMENT TECHNOLOGIES
1340 HOME AVE. , BLDG A
AKRON,  OH  44310
Applicant Contact JOSHUA LEFKOVITZ
Correspondent
PAIN MANAGEMENT TECHNOLOGIES
1340 HOME AVE. , BLDG A
AKRON,  OH  44310
Correspondent Contact JOSHUA LEFKOVITZ
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/25/2008
Decision Date 01/06/2009
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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