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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, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW
Applicant Contact JENNY HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #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
Predetermined Change
Control Plan Authorized		 No
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