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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, #5, Sec.5, Hsin Yi Rd.
Taipei,  TW 106
Applicant Contact JENNY HSIAH
Correspondent
Well-Life Healthcare, Inc.
6c01, #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
Predetermined Change
Control Plan Authorized		 No
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