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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K024100
Device Name IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
Applicant
THERATECH, INC.
NO.5,ALLEY 5,LANG CHENG HSING,
CHUNG CHING RD,PEI TUN DIST.
TAICHUNG,  TW R.O.C
Applicant Contact TONY C.S. CHANG
Correspondent
THERATECH, INC.
NO.5,ALLEY 5,LANG CHENG HSING,
CHUNG CHING RD,PEI TUN DIST.
TAICHUNG,  TW R.O.C
Correspondent Contact TONY C.S. CHANG
Regulation Number882.5890
Classification Product Code
LIH  
Date Received12/12/2002
Decision Date 02/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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