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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 K880744
Device Name ANESTY 10
Applicant
Nihon Medix Co., Ltd.
C/O Regulatory Assistance Corp
Rd3 Clearview Cir.
Hopewell Junction,  NY  12533
Applicant Contact DEBORAH A KUTER
Correspondent
Nihon Medix Co., Ltd.
C/O Regulatory Assistance Corp
Rd3 Clearview Cir.
Hopewell Junction,  NY  12533
Correspondent Contact DEBORAH A KUTER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/24/1988
Decision Date 02/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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