FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K200262 |
Bioness Inc. |
L100 Go System |
03/04/2020 |
K162407 |
BIONESS INC. |
L300 Go System |
01/27/2017 |
K190285 |
Bioness Inc. |
L300 Go System |
03/14/2019 |
K103343 |
BIONESS INC. |
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) |
04/29/2011 |
K191587 |
Bioness Inc. |
L360 Thigh System |
09/12/2019 |
K123636 |
BIONESS, INC. |
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
05/01/2013 |
K173682 |
Bioness, Inc. |
L300 Go System |
03/09/2018 |
K122784 |
BIONESS, INC. |
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT |
12/27/2012 |
K120853 |
BIONESS, INC. |
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
04/20/2012 |
K213622 |
CIONIC |
Cionic Neural Sleeve NS-100 |
02/14/2022 |
K221823 |
CIONIC |
Cionic Neural Sleeve NS-100 |
07/21/2022 |
K050991 |
DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. |
THE ODFS DROPPED FOOT STIMULATOR |
07/15/2005 |
K202110 |
Guangzhou Longest Science & Technology CO., Ltd. |
MStim Drop Model: LGT-233 |
11/05/2021 |
K073237 |
HASOMED GMBH |
REHASTIM & REHAMOVE |
12/27/2007 |
K162683 |
HASOMED GmbH |
RehaStim 2 |
02/03/2017 |
K132416 |
HASOMED GMBH |
REHASTIM 2, ERIGOPRO (FES) |
05/28/2014 |
K112844 |
HASOMED GMBH |
REHASTIM 2, REHAMOVE 2 |
10/27/2011 |
K123972 |
INNOVATIVE NEUROTRONICS INC. |
WALKAIDE SYSTEM |
04/01/2013 |
K140886 |
INNOVATIVE NEUROTRONICS INC. |
WALKAIDE SYSTEM |
08/08/2014 |
K052329 |
INNOVATIVE NEUROTRONICS INC. |
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 |
09/21/2005 |
K170564 |
MyndTec Inc |
MyndMove System, MyndMove Functional Electrical Stimulator |
08/30/2017 |
K212149 |
MyndTec Inc. |
MyndMove 2.0 |
03/03/2022 |
K170132 |
MYOLYN, LLC |
MyoCycle Home, MyoCycle Pro |
04/25/2017 |
K213925 |
Myolyn, LLC |
MyoCycle MC-2 (Home / Home + / Pro / Pro +) |
04/25/2022 |
K031900 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
HANDMASTER |
08/08/2003 |
K012823 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
MODIFICATION TO HANDMASTER |
11/14/2001 |
K080219 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
MODIFICATION TO:NESS L300 |
02/28/2008 |
K111767 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT |
09/15/2011 |
K053468 |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
NESS L300 |
07/07/2006 |
K974514 |
NEUROMOTION, INC. |
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR |
02/06/1998 |
K010837 |
NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD. |
HANDMASTER |
06/15/2001 |
K102115 |
ODSTOCK MEDICAL LTD |
ODFS PACE |
03/30/2011 |
K171396 |
Odstock Medical Ltd |
ODFS Pace XL |
01/31/2018 |
K141812 |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
MYGAIT STIMULATION SYSTEM |
04/02/2015 |
K153163 |
Rehabtronics Inc. |
ReGrasp |
04/07/2016 |
K050036 |
RESTORATIVE THERAPIES INC. |
FES CYCLE ERGOMETER, MODEL RT300-S |
06/27/2005 |
K103370 |
RESTORATIVE THERAPIES INC. |
RT200 |
04/05/2011 |
K072398 |
RESTORATIVE THERAPIES INC. |
RT300-S AND RT300-SP FES CYCLE ERGOMETER |
11/21/2007 |
K071113 |
RESTORATIVE THERAPIES INC. |
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 |
07/05/2007 |
K060032 |
RESTORATIVE THERAPIES INC. |
RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 |
03/10/2006 |
K071486 |
RESTORATIVE THERAPIES INC. |
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 |
09/10/2007 |
K090750 |
RESTORATIVE THERAPIES INC. |
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 |
08/05/2009 |
K103366 |
RESTORATIVE THERAPIES INC. |
RT600 |
04/04/2011 |
K162470 |
Restorative Therapies, Inc. |
RT300 FES cycle ergometer |
07/11/2017 |
K162718 |
SHENZHEN XFT Medical Limited |
Foot Drop System (Model XFT-2001D) |
11/30/2017 |
K193276 |
Shenzhen XFT Medical Limited |
Nerve and Muscle Stimulator |
09/23/2020 |
K131923 |
TECHLINK INTERNATIONAL |
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS |
07/03/2014 |