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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 K123075
Device Name BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E
Applicant
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW CH
Applicant Contact CHIN-CHIH HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW CH
Correspondent Contact CHIN-CHIH HSIEH
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/01/2012
Decision Date 07/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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