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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
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