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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 K193655
Device Name MSLS6QF TENS/PMS Device
Applicant
Self Doctor Care, LLC
8811 Teel Pkwy Ste 100, Unit 6141
Frisco,  TX  75036
Applicant Contact Wei Wei
Correspondent
Self Doctor Care, LLC
8811 Teel Pkwy Ste 100, Unit 6141
Frisco,  TX  75036
Correspondent Contact Wei Wei
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/30/2019
Decision Date 09/04/2020
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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