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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
Applicant
Tenscare, Ltd.
9 Blenheim Rd., Longmead Business Park,
Epsom,  GB KT19 9BE
Applicant Contact Andrew Brown
Correspondent
Tenscare, Ltd.
9 Blenheim Rd., Longmead Business Park,
Epsom,  GB KT19 9BE
Correspondent Contact Andrew Brown
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
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
Predetermined Change
Control Plan Authorized		 No
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