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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K240632
Device Name Neuvotion NeuStim NN-01
Applicant
Neuvotion, Inc.
165 Club Rd.
Stamford,  CT  06905
Applicant Contact Chad Bouton
Correspondent
Neuvotion, Inc.
165 Club Rd.
Stamford,  CT  06905
Correspondent Contact Chad Bouton
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received03/06/2024
Decision Date 11/22/2024
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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