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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 K213091
Device Name Well-Life TENS/EMS/Heating Stimulator
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 Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IRT   NGX  
Date Received09/24/2021
Decision Date 02/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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