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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 K002874
Device Name WELL-TENS
Applicant
Well-Life Consultant
6co1,#5.Sec.5,Hsin Yi Rd.
Taipei,  TW
Applicant Contact KEVIN CHIU
Correspondent
Well-Life Consultant
6co1,#5.Sec.5,Hsin Yi Rd.
Taipei,  TW
Correspondent Contact KEVIN CHIU
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/14/2000
Decision Date 07/27/2001
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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