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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 K082377
Device Name TENSCARE ITOUCH MODEL(S) EASY AND PLUS
Applicant
Tenscare, Ltd.
9 Blenheim Rd.
Epsom,  GB KT199BE
Applicant Contact ANTHONY JANKEL
Correspondent
Tenscare, Ltd.
9 Blenheim Rd.
Epsom,  GB KT199BE
Correspondent Contact ANTHONY JANKEL
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/18/2008
Decision Date 02/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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