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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K072168
Device Name OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412
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 Number890.5850
Classification Product Code
NGX  
Date Received08/06/2007
Decision Date 12/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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