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Bioness, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K211965StimRouter Neuromodulation SystemFebruary 23, 2022
K200482StimRouter Neuromodulation SystemMarch 27, 2020
K200262L100 Go SystemMarch 4, 2020
K190047StimRouter Neuromodulation SystemOctober 31, 2019
K191587L360 Thigh SystemSeptember 12, 2019
K190285L300 Go SystemMarch 14, 2019
K173682L300 Go SystemMarch 9, 2018
K162407L300 Go SystemJanuary 27, 2017
K142432StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitFebruary 20, 2015
K123636H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICEMay 1, 2013
K122784NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L30December 27, 2012
K120853NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NEApril 20, 2012
K103343L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)April 29, 2011