Stimulator, Neuromuscular, External Functional

FDA product code GZI · 57 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5810
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-04-26 – 2025-06-05

GZI 2025-06-05

Synchrony (20-3000)

Applicant Synapse Biomedical, Inc.

K number K242704

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GZI 2025-05-02

CIONIC NEURAL SLEEVE (NS-200)

Applicant Cionic, Inc.

K number K243828

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GZI 2024-11-22

Neuvotion NeuStim NN-01

Applicant Neuvotion, Inc.

K number K240632

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GZI 2024-06-25

MyndMove, MyndMove 2.0

Applicant Myndtec, Inc.

K number K233006

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GZI 2023-12-28

EvoWalk 1.0 System

Applicant Evolution Devices, Inc.

K number K230997

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GZI 2022-07-21

Cionic Neural Sleeve NS-100

Applicant Cionic

K number K221823

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GZI 2022-04-25

MyoCycle MC-2 (Home / Home + / Pro / Pro +)

Applicant Myolyn, LLC

K number K213925

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GZI 2022-03-03

MyndMove 2.0

Applicant Myndtec, Inc.

K number K212149

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GZI 2022-02-14

Cionic Neural Sleeve NS-100

Applicant Cionic

K number K213622

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GZI 2021-11-05

MStim Drop Model: LGT-233

Applicant Guangzhou Longest Science & Technology Co., Ltd.

K number K202110

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GZI 2020-09-23

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K number K193276

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GZI 2020-03-04

L100 Go System

Applicant Bioness, Inc.

K number K200262

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GZI 2019-09-12

L360 Thigh System

Applicant Bioness, Inc.

K number K191587

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GZI 2019-03-14

L300 Go System

Applicant Bioness, Inc.

K number K190285

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GZI 2018-03-09

L300 Go System

Applicant Bioness, Inc.

K number K173682

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GZI 2018-01-31

ODFS Pace XL

Applicant Odstock Medical, Ltd.

K number K171396

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GZI 2017-11-30

Foot Drop System (Model XFT-2001D)

Applicant Shenzhen Xft Medical Limited

K number K162718

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GZI 2017-08-30

MyndMove System, MyndMove Functional Electrical Stimulator

Applicant Myndtec, Inc.

K number K170564

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GZI 2017-07-11

RT300 FES cycle ergometer

Applicant Restorative Therapies, Inc.

K number K162470

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GZI 2017-04-25

MyoCycle Home, MyoCycle Pro

Applicant Myolyn, LLC

K number K170132

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GZI 2017-02-03

RehaStim 2

Applicant Hasomed GmbH

K number K162683

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GZI 2017-01-27

L300 Go System

Applicant Bioness, Inc.

K number K162407

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GZI 2016-04-07

ReGrasp

Applicant Rehabtronics, Inc.

K number K153163

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GZI 2013-05-01

H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE

Applicant Bioness, Inc.

K number K123636

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GZI 2013-04-01

WALKAIDE SYSTEM

Applicant Innovative Neurotronics, Inc.

K number K123972

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GZI 2012-12-27

NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT

Applicant Bioness, Inc.

K number K122784

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GZI 2012-04-20

NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,

Applicant Bioness, Inc.

K number K120853

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GZI 2011-10-27

REHASTIM 2, REHAMOVE 2

Applicant Hasomed GmbH

K number K112844

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GZI 2011-09-15

NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT

Applicant Ness-Neuromuscular Electrical Stimulation Systems

K number K111767

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GZI 2011-04-29

L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)

Applicant Bioness, Inc.

K number K103343

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GZI 2011-04-05

RT200

Applicant Restorative Therapies, Inc.

K number K103370

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GZI 2011-04-04

RT600

Applicant Restorative Therapies, Inc.

K number K103366

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GZI 2011-03-30

ODFS PACE

Applicant Odstock Medical, Ltd.

K number K102115

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GZI 2009-08-05

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581

Applicant Restorative Therapies, Inc.

K number K090750

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GZI 2008-02-28

MODIFICATION TO:NESS L300

Applicant Ness-Neuromuscular Electrical Stimulation Systems

K number K080219

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GZI 2007-12-27

REHASTIM & REHAMOVE

Applicant Hasomed GmbH

K number K073237

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GZI 2007-11-21

RT300-S AND RT300-SP FES CYCLE ERGOMETER

Applicant Restorative Therapies, Inc.

K number K072398

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GZI 2007-09-10

RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053

Applicant Restorative Therapies, Inc.

K number K071486

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GZI 2007-07-05

RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053

Applicant Restorative Therapies, Inc.

K number K071113

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GZI 2006-07-07

NESS L300

Applicant Ness-Neuromuscular Electrical Stimulation Systems

K number K053468

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GZI 2006-03-10

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053

Applicant Restorative Therapies, Inc.

K number K060032

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GZI 2005-09-21

WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000

Applicant Innovative Neurotronics, Inc.

K number K052329

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GZI 2005-07-15

THE ODFS DROPPED FOOT STIMULATOR

Applicant Department of Medical Physics and Biomedical Eng.

K number K050991

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GZI 2005-06-27

FES CYCLE ERGOMETER, MODEL RT300-S

Applicant Restorative Therapies, Inc.

K number K050036

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GZI 2003-08-08

HANDMASTER

Applicant Ness-Neuromuscular Electrical Stimulation Systems

K number K031900

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GZI 2001-11-14

MODIFICATION TO HANDMASTER

Applicant Ness-Neuromuscular Electrical Stimulation Systems

K number K012823

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GZI 2001-06-15

HANDMASTER

Applicant Neuromusclar Electrical Stimulation Systems, Ltd.

K number K010837

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GZI 1998-02-06

EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR

Applicant Neuromotion, Inc.

K number K974514

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GZI 1995-03-16

FORTE ES

Applicant Chattanooga Group, Inc.

K number K940759

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GZI 1992-02-07

COMFORTRON PT (TENS)

Applicant M. D. Supply, Inc.

K number K911066

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GZI 1991-09-27

ROCHE COBAS ARGOS 5 DIFF

Applicant Roche Diagnostic Systems, Inc.

K number K912615

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GZI 1991-08-09

SELECT NEUROMUSCULAR STIMULATORS

Applicant Medtronic Vascular

K number K903434

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GZI 1987-09-30

TENS LEAD

Applicant Desco Industries, Inc.

K number K873608

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GZI 1982-01-19

VERI/DFS TM #817

Applicant Verite

K number K813515

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GZI 1980-03-17

FES ORTHOSIS MODEL NO. 2000

Applicant Empi

K number K800380

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GZI 1977-06-14

NERVE STIMULATOR, MOLEL NO. FB-800

Applicant Output, Inc.

K number K770987

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GZI 1977-04-26

STIMULATOR, MUSCLE, MODEL 107

Applicant Jaytronics, Inc.

K number K770725

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