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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, For Pain Relief
510(k) Number K181645
Device Name StimaWELL 120MTRS
Applicant
Pierenkemper GmbH
Am Geiersberg 6
Ehringshausen,  DE 35630
Applicant Contact Thorsten Reichel
Correspondent
Emergo Global Consulting
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Andre Kindsvater
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received06/22/2018
Decision Date 08/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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