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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K220524
Device Name Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
Applicant
Well-Life Healthcare Limited
6f. #168, Lide St., Jhonghe District
New Taipei City,  TW 23512
Applicant Contact Jenny Hsieh
Correspondent
Well-Life Healthcare Limited
6f. #168, Lide St., Jhonghe District
New Taipei City,  TW 23512
Correspondent Contact Jenny Hsieh
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received02/23/2022
Decision Date 08/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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