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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K220994
Device Name Shoulder PacemakerTM
Applicant
Ncs Lab Srl
Via Pola Esterna 4/12
Carpi,  MO  41012
Applicant Contact Matteo Mantovani
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Tim Marjenin
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
HCC   KQX  
Date Received04/04/2022
Decision Date 10/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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