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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 K090023
Device Name IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
Applicant
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY,  TW
Applicant Contact JENNY HSIEH
Correspondent
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY,  TW
Correspondent Contact JENNY HSIEH
Regulation Number882.5890
Classification Product Code
LIH  
Date Received01/05/2009
Decision Date 01/30/2009
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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