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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, Over-The-Counter
510(k) Number K063743
Device Name RHYTHM TOUCH Q 2-WAY
Applicant
Shockim Enterprises, Ltd.
28711 Jaeger Dr.
Laguna Niguel,  CA  92677
Applicant Contact NICOLAAS C BESSELING
Correspondent
Shockim Enterprises, Ltd.
28711 Jaeger Dr.
Laguna Niguel,  CA  92677
Correspondent Contact NICOLAAS C BESSELING
Regulation Number882.5890
Classification Product Code
NUH  
Date Received12/18/2006
Decision Date 05/24/2007
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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