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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, peripheral nerve, implanted (pain relief)
510(k) Number K211965
Device Name StimRouter Neuromodulation System
Bioness Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Sageev George
Bioness Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Sageev George
Regulation Number882.5870
Classification Product Code
Date Received06/24/2021
Decision Date 02/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No