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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K202234
Device Name NervAlign Nerve Cuff
Applicant
Renerve, Ltd.
Suite 3, 21 Vale St.
North Melbourne,  AU 3051
Applicant Contact David Rhodes
Correspondent
Sloan Regulatory Consulting, LLC
322 Hart Rd.
Gaithersburg,  MD  20878
Correspondent Contact Chris Sloan
Regulation Number882.5275
Classification Product Code
JXI  
Date Received08/07/2020
Decision Date 02/10/2022
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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