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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percutaneous Nerve Stimulator For Opioid Withdrawal
510(k) Number K233166
Device Name NET Recovery Corp/NET Device
Applicant
Net Recovery
155 N Riverview Dr, Suite 114
Anaheim Hills,  CA  92808
Applicant Contact Joe Winston
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number882.5896
Classification Product Code
PZR  
Date Received09/27/2023
Decision Date 05/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04916600
Reviewed by Third Party No
Combination Product No
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