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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 K102786
Device Name WELL-LIFE OTC EMS SYSTEM
Applicant
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Applicant Contact JENNY HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Correspondent Contact JENNY HSIEH
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/27/2010
Decision Date 07/01/2011
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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