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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 K081255
Device Name SCRAMBLER ST 5 TENS DEVICE
Applicant
Competitive Technologies,Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA
Correspondent
Competitive Technologies,Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/02/2008
Decision Date 02/20/2009
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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