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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 K033857
Device Name T-TECH DIGITAL, MODEL WL-22XXA SERIES
Applicant
WELL-LIFE HEALTHCARE, INC.
6C01, NO.5, SEC.5, HSIN YI RD.
TAIPEI,  TW 106
Applicant Contact JENNY HSIAH
Correspondent
WELL-LIFE HEALTHCARE, INC.
6C01, NO.5, SEC.5, HSIN YI RD.
TAIPEI,  TW 106
Correspondent Contact JENNY HSIAH
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received12/11/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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