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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 K213622
Device Name Cionic Neural Sleeve NS-100
Applicant
Cionic
1606 Stockton St., Suite #1
San Francisco,  CA  94133
Applicant Contact Mihai Ionescu
Correspondent
Cionic
1606 Stockton St., Suite #1
San Francisco,  CA  94133
Correspondent Contact Mihai Ionescu
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received11/16/2021
Decision Date 02/14/2022
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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