Bioness Inc

FDA Filings

This page includes the latest FDA filings for Bioness Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Bioness Inc.
L100 Go System2020-03-04
Bioness Inc.
StimRouter Neuromodulation System2019-10-31
Bioness Inc.
L360 Thigh System2019-09-12
Bioness Inc.
L300 Go System2019-03-14
Bioness, Inc.
L300 Go System2018-03-09
BIONESS INC.
L300 Go System2017-01-27
BIONESS, INC.
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit2015-02-20
BIONESS, INC.
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE2013-05-01
BIONESS, INC.
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT2012-12-27
BIONESS, INC.
Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,2012-04-20
BIONESS INC.
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)2011-04-29

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
NESS L300 Foot Drop System
BIONESS INC.2019-11-08
NESS L300 Foot Drop System
BIONESS INC.2019-11-08
NESS L300 Foot Drop System
BIONESS INC.2019-11-08
NESS L300 Foot Drop System
BIONESS INC.2019-11-08
NESS L300 Foot Drop System
BIONESS INC.2019-11-08
NESS L300-Plus System
BIONESS INC.2019-11-08
NESS L300-Plus System
BIONESS INC.2019-11-08
NESS L300-Plus System
BIONESS INC.2019-11-08
NESS L300-Plus System
BIONESS INC.2019-11-08
NESS L300-Plus System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
NESS H200® Wireless Hand Rehabilitation System
BIONESS INC.2019-11-08
L300 Go System
BIONESS INC.2019-11-08
L300 Go System, Right Thigh Plus
BIONESS INC.2019-11-08
L300 Go System, Right Small Lower Leg
BIONESS INC.2019-11-08
L300 Go System, Right Lower Leg
BIONESS INC.2019-11-08
L300 Go System, Left Thigh Stand-Alone
BIONESS INC.2019-11-08
L300 Go System, Left Thigh Plus
BIONESS INC.2019-11-08
L300 Go System, Left Small Lower Leg
BIONESS INC.2019-11-08
L300 Go System, Left Lower Leg
BIONESS INC.2019-11-08
L300 Go Clinician Kit
BIONESS INC.2019-11-08
L300 Go Clinician Programmer Software
BIONESS INC.2019-11-08
H200 Wireless System
BIONESS INC.2019-10-23
H200 Wireless System
BIONESS INC.2019-10-23
H200 Wireless System
BIONESS INC.2019-10-23
H200 Wireless System
BIONESS INC.2019-10-23
H200 Wireless System
BIONESS INC.2019-10-23
H200 Wireless System
BIONESS INC.2019-10-23
H200 Wireless System
BIONESS INC.2019-10-23

Related Finance Registrations

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