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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K200942
Device Name Well-Life Garment Electrodes (GM Series)
Applicant
Well-Life Healthcare Limited
6f., No, 168, Lide St., Jhonghe District
New Taipei City,  TW 235
Applicant Contact Jenny Hsieh
Correspondent
Well-Life Healthcare Limited
6f., No, 168, Lide St., Jhonghe District
New Taipei City,  TW 235
Correspondent Contact Jenny Hsieh
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/08/2020
Decision Date 06/01/2021
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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