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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 K200694
Device Name Perfect EMS
TensCare Ltd.
9 Blenheim Road, Longmead Business Park
Epsom,  GB KT19 9BE
Applicant Contact Andrew Brown
TensCare Ltd.
9 Blenheim Road, Longmead Business Park,
Epsom,  GB KT19 9BE
Correspondent Contact Andrew Brown
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received03/17/2020
Decision Date 06/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No