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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., No. 168. de St., Jhonghe District
New Taipei City,  TW 235
Applicant Contact Jenny Hsieh
Correspondent
Well-Life Healthcare Limited
6F., No. 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
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