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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 K052182
Device Name SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
Applicant
Shian Jia Meei Enterprise Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Shian Jia Meei Enterprise Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/10/2005
Decision Date 11/04/2005
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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