Bioness Inc

FDA Filings

This page includes the latest FDA filings for Bioness Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Bioness Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9616784
FEI Number3007035078
NameMercedes Bayani
Owner & OperatorBIONESS INC.
Contact Address25103 RYE CANYON LOOP
Valencia CA 91355 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBioness 25103 Rye Canyon Loop
Valencia, CA 91355 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number3004553866
FEI Number3004553866
NameBIONESS INC.
Owner & OperatorBIONESS INC.
Contact Address25103 RYE CANYON LOOP
Valencia CA 91355 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address25103 RYE CANYON LOOP
Valencia, CA 91355 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
BIONESS INC.
 StimRouter User Kit 2022-10-25
Bioness Inc.
StimRouter Neuromodulation System2022-02-23
BIONESS INC.
 BITS Motion Sensor 2020-08-18
BIONESS INC.
 Bioness Integrated Therapy System, BITS 3.0, BITS Balance 2020-08-18
BIONESS INC.
 Bioness Integrated Therapy System, BITS 3.0, BITS Balance 2020-08-18
BIONESS INC.
 L100 Go System 2020-04-30
BIONESS INC.
 L100 Go System 2020-04-30
Bioness Inc.
StimRouter Neuromodulation System2020-03-27
BIONESS INC.
L100 Go System2020-03-18
BIONESS INC.
L100 Go System2020-03-18
Bioness Inc.
L100 Go System2020-03-04
BIONESS INC.
 NESS L300 Foot Drop System 501-00170-012019-11-08
BIONESS INC.
 NESS L300 Foot Drop System 501-00169-012019-11-08
BIONESS INC.
 NESS L300 Foot Drop System 501-00161-012019-11-08
BIONESS INC.
 NESS L300 Foot Drop System 501-00159-012019-11-08
BIONESS INC.
 NESS L300 Foot Drop System 501-00158-012019-11-08
BIONESS INC.
 NESS L300-Plus System 501-00046-012019-11-08
BIONESS INC.
 NESS L300-Plus System 501-00127-012019-11-08
BIONESS INC.
 NESS L300-Plus System 501-00126-012019-11-08
BIONESS INC.
 NESS L300-Plus System 501-00123-012019-11-08
BIONESS INC.
 NESS L300-Plus System 501-00122-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00176-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00120-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00095-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00094-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00042-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00041-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00038-012019-11-08
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00037-012019-11-08
BIONESS INC.
 L300 Go System L300 Go System, Right Thigh Stand-Alone2019-11-08
BIONESS INC.
 L300 Go System, Right Thigh Plus 2019-11-08
BIONESS INC.
 L300 Go System, Right Small Lower Leg 2019-11-08
BIONESS INC.
 L300 Go System, Right Lower Leg 2019-11-08
BIONESS INC.
 L300 Go System, Left Thigh Stand-Alone 2019-11-08
BIONESS INC.
 L300 Go System, Left Thigh Plus 2019-11-08
BIONESS INC.
 L300 Go System, Left Small Lower Leg 2019-11-08
BIONESS INC.
 L300 Go System, Left Lower Leg 2019-11-08
BIONESS INC.
 L300 Go Clinician Kit 2019-11-08
BIONESS INC.
 L300 Go Clinician Programmer Software 2019-11-08
Bioness Inc.
StimRouter Neuromodulation System2019-10-31
BIONESS INC.
 NESS H200® Wireless Hand Rehabilitation System 501-00121-012019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 H200 Wireless System 2019-10-23
BIONESS INC.
 L360 Thigh System 2019-10-08
BIONESS INC.
 L360 Thigh System 2019-10-08
Bioness Inc.
L360 Thigh System2019-09-12
BIONESS INC.
L360 Thigh System2019-09-12
BIONESS INC.
L360 Thigh System2019-09-12
BIONESS INC.
 H200 Wireless System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 L300 Go System 2019-06-24
BIONESS INC.
 Bioness StimRouter Extended Hydrogel Electrode Set 2019-04-08
BIONESS INC.
 Bioness L300 Go Hydrogel Electrodes 2019-03-18
BIONESS INC.
L300 Go System2019-03-18
BIONESS INC.
L300 Go System2019-03-18
Bioness Inc.
L300 Go System2019-03-14
BIONESS INC.
 StimRouter 2018-07-06
BIONESS INC.
 H200 Wireless 2018-07-06
BIONESS INC.
 StimRouter User Kit 2018-07-06
BIONESS INC.
 StimRouter Clinician's Kit 2018-07-06
BIONESS INC.
 StimRouter Implantable Kit 2018-07-06
BIONESS INC.
L300 Go System2018-06-29
BIONESS INC.
L300 Go System2018-06-29
BIONESS INC.
 StimRouter Electrode Set 2018-06-11
BIONESS INC.
 Vector Base 2018-03-29
BIONESS INC.
 Vector Elite 2018-03-29
BIONESS INC.
 Vector Elite 2018-03-29
BIONESS INC.
 Bioness Integrated System (BITS)2.0.5 2018-03-29
BIONESS INC.
 Bioness Integrated System (BITS)2.0.5 2018-03-29
BIONESS INC.
 Bioness Integrated System (BITS)2.0.5 2018-03-29
BIONESS INC.
 Bioness Integrated System (BITS) Mobile Configuration 2018-03-29
BIONESS INC.
 Bioness Integrated System (BITS) Bedside Configuration 2018-03-29
BIONESS INC.
 Bioness Integrated System (BITS)2.0.5 2018-03-29
Bioness, Inc.
L300 Go System2018-03-09
BIONESS INC.
L300 Go System2017-02-10
BIONESS INC.
L300 Go System2017-02-10
BIONESS INC.
L300 Go System2017-01-27
Mercedes Bayani [BIONESS INC.]
Ness L300 Foot Drop System or L300 Foot Drop System2016-09-08
BIONESS INC.
Ness L300 Foot Drop System or L300 Foot Drop System2016-09-08
Mercedes Bayani [BIONESS INC.]
Ness L300 Foot Drop System or L300 Foot Drop System2016-09-08
BIONESS INC.
Ness L300 Foot Drop System or L300 Foot Drop System2016-09-08
BIONESS INC.
StimRouter Neuromodulation System2015-04-28
BIONESS, INC.
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit2015-02-20
BIONESS INC.
Bioness Integrated Therapy System (BITS)2014-08-22
BIONESS INC.
BIT-22242014-08-22
BIONESS INC.
BIT-21242014-08-22
BIONESS INC.
BIT-20552014-08-22
BIONESS INC.
BIT-20482014-08-22
BIONESS INC.
BIT-10652014-08-22
BIONESS INC.
BIT-10552014-08-22
BIONESS INC.
BIT-10462014-08-22
BIONESS INC.
H200 Wireless System2014-03-13
BIONESS INC.
H200 Wireless System2014-03-13
BIONESS INC.
Vector Gait and Safety System2013-10-21
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.
NESS H200 Wireless Hand Rehabilitation System2011-09-26
Mercedes Bayani [BIONESS INC.]
L300 Plus Sysem2011-05-05
BIONESS INC.
L300 Plus Sysem2011-05-05
Mercedes Bayani [BIONESS INC.]
L300 Plus Sysem2011-05-05
BIONESS INC.
L300 Plus Sysem2011-05-05
BIONESS INC.
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)2011-04-29
Mercedes Bayani [BIONESS INC.]
NESS L300 Plus System2009-11-20
BIONESS INC.
NESS L300 Plus System2009-11-20
Mercedes Bayani [BIONESS INC.]
NESS L300 System2006-12-01
Mercedes Bayani [BIONESS INC.]
L3002006-12-01
Mercedes Bayani [BIONESS INC.]
L300 Foot Drop System2006-12-01
BIONESS INC.
NESS L300 System2006-12-01
BIONESS INC.
L3002006-12-01
BIONESS INC.
L300 Foot Drop System2006-12-01
Mercedes Bayani [BIONESS INC.]
H2002005-01-05
Mercedes Bayani [BIONESS INC.]
H200 Hand Rehabilitation System2005-01-05
Mercedes Bayani [BIONESS INC.]
H2002005-01-05
Mercedes Bayani [BIONESS INC.]
H200 Hand Rehabilitation System2005-01-05

Related Finance Registrations
NCAGE Code4ACX4BIONESS INC.
CAGE Code4ACX4BIONESS INC.
S.A.M. Registration4ACX4 [182287727]BIONESS INC.
SEC0001424968BIONESS INC of DELAWARE
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020070338230Hong Kong,Hong Kong -> Long Beach, CaliforniaPOWER ADAPTER FOR MOBILE PHONE SCAC CODE: TECB AMS NO# FSZX20061468 . . . .25 CTN
2019113054023Hong Kong,Hong Kong -> Long Beach, CaliforniaPOWER ADAPTER FOR MOBILE PHONE (HS CODE:85044 0) BRAND NAME: HOMESPOT MODEL NO.: KSA01A5210 10005 24CTNS=1PLTS+8CTNS=9PKGS24 CTN
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