FDA 510(k) Applications Submitted by Bioness Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K103343 11/15/2010 L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) BIONESS INC.
K200262 02/03/2020 L100 Go System Bioness Inc.
K190285 02/11/2019 L300 Go System Bioness Inc.
K191587 06/14/2019 L360 Thigh System Bioness Inc.
K162407 08/29/2016 L300 Go System BIONESS INC.
K190047 01/09/2019 StimRouter Neuromodulation System Bioness Inc.
K200482 02/27/2020 StimRouter Neuromodulation System Bioness Inc.
K211965 06/24/2021 StimRouter Neuromodulation System Bioness Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact