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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K081943
Device Name MODEL ES-130
Applicant
Ito Co., Ltd.
1201 Richardson Dr.
Suite 140
Richardson,  TX  75080
Applicant Contact KENNETH L BLOCK
Correspondent
Ito Co., Ltd.
1201 Richardson Dr.
Suite 140
Richardson,  TX  75080
Correspondent Contact KENNETH L BLOCK
Classification Product Code
BWK  
Date Received07/08/2008
Decision Date 11/24/2008
Decision Substantially Equivalent (SESE)
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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