Medical Device Manufacturer · US , Valencia , CA

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

13 submissions · 13 cleared · Since 2011
13
Total
13
Cleared
0
Denied

Bioness, Inc. has 13 FDA 510(k) cleared neurology devices. Based in Valencia, US.

Last cleared in 2022. Active since 2011.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

13 devices
1-13 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
Cleared Apr 29, 2011
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
K103343 · GZI
Neurology · 165d
Filters
Filter by Specialty
All13 Neurology 13