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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K222528
Device Name Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
Applicant
Well-Life Healthcare Limited
6f., # 168. De St., Jhonghe District
New Taipei City,  TW 235
Applicant Contact Jenny Hsieh
Correspondent
Well-Life Healthcare Limited
6f., # 168. De St., Jhonghe District
New Taipei City,  TW 235
Correspondent Contact Jenny Hsieh
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received08/22/2022
Decision Date 12/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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