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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 K091045
Device Name SMART TENS, MODEL: D-BC05T
Applicant
Body Clock Health Care, Ltd.
108 George Lane
London, England,  GB E18 1AD
Applicant Contact RASHELLE PRESTON
Correspondent
Body Clock Health Care, Ltd.
108 George Lane
London, England,  GB E18 1AD
Correspondent Contact RASHELLE PRESTON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/13/2009
Decision Date 12/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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