Medical Device Manufacturer · US , Valencia , CA

Bioness, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2011

Recent clearances: StimRouter Neuromodulation System, StimRouter Neuromodulation System, L100 Go System

13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Bioness, Inc. Neurology ✕

13 devices
1-12 of 13
Cleared Feb 23, 2022
StimRouter Neuromodulation System
K211965 · GZF
Neurology · 244d
Cleared Mar 27, 2020
StimRouter Neuromodulation System
K200482 · GZF
Neurology · 29d
Cleared Mar 04, 2020
L100 Go System
K200262 · GZI
Neurology · 30d
Cleared Oct 31, 2019
StimRouter Neuromodulation System
K190047 · GZF
Neurology · 295d
Cleared Sep 12, 2019
L360 Thigh System
K191587 · GZI
Neurology · 90d
Cleared Mar 14, 2019
L300 Go System
K190285 · GZI
Neurology · 31d
Cleared Mar 09, 2018
L300 Go System
K173682 · GZI
Neurology · 98d
Cleared Jan 27, 2017
L300 Go System
K162407 · GZI
Neurology · 151d
Cleared Feb 20, 2015
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician...
K142432 · GZF
Neurology · 175d
Cleared May 01, 2013
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT...
K123636 · GZI
Neurology · 159d
Cleared Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
K122784 · GZI
Neurology · 107d
Cleared Apr 20, 2012
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300...
K120853 · GZI
Neurology · 30d
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