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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 K210674
Device Name Shoulder Pacemaker
Applicant
Ncs Lab Srl
Via Pola Esterna 4/12
Carpi,  IT 41012
Applicant Contact Matteo Mantovani
Correspondent
Ncs Lab Srl
Via Pola Esterna 4/12
Carpi,  IT
Correspondent Contact Matteo Mantovani
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
KQX  
Date Received03/05/2021
Decision Date 08/24/2021
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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