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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 K191587
Device Name L360 Thigh System
Bioness Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Applicant Contact Mercedes Bayani
Bioness Inc.
25103 Rye Canyon Loop
Valencia,  CA  91355
Correspondent Contact Shanna Hu
Regulation Number882.5810
Classification Product Code
Subsequent Product Code
Date Received06/14/2019
Decision Date 09/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No