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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 K071120
Device Name AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
Applicant
Aemed, Inc.
6530 SW 49th Terrace
South Miami,  FL  33155
Applicant Contact RALPH JUGO
Correspondent
Aemed, Inc.
6530 SW 49th Terrace
South Miami,  FL  33155
Correspondent Contact RALPH JUGO
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/20/2007
Decision Date 03/13/2008
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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