Product Code: GZI FDA class 2 21 CFR 882.5810

Stimulator, Neuromuscular, External Functional

Neurology

The External Functional Neuromuscular Stimulator is a non-implanted device that delivers electrical stimulation to nerves or muscles through surface electrodes to produce functional movement, used in rehabilitation of patients with conditions such as stroke-related hemiplegia or foot drop. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZI under regulation 21 CFR 882.5810 in the Neurology specialty. It is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: GZI
Device Class: FDA class 2
Regulation Number: 882.5810
Medical Specialty: Neurology
Review Panel: NE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242704	Synchrony (20-3000)	Jun 05, 2025	Substantially Equivalent	Synapse Biomedical, Inc.
K243828	CIONIC NEURAL SLEEVE (NS-200)	May 02, 2025	Substantially Equivalent	Cionic, Inc.
K240632	Neuvotion NeuStim NN-01	Nov 22, 2024	Substantially Equivalent	Neuvotion, Inc.
K233006	MyndMove, MyndMove 2.0	Jun 25, 2024	Substantially Equivalent	Myndtec, Inc.
K230997	EvoWalk 1.0 System	Dec 28, 2023	Substantially Equivalent	Evolution Devices, Inc.
K221823	Cionic Neural Sleeve NS-100	Jul 21, 2022	Substantially Equivalent	Cionic
K213925	MyoCycle MC-2 (Home / Home + / Pro / Pro +)	Apr 25, 2022	Substantially Equivalent	Myolyn, LLC
K212149	MyndMove 2.0	Mar 03, 2022	Substantially Equivalent	Myndtec, Inc.
K213622	Cionic Neural Sleeve NS-100	Feb 14, 2022	Substantially Equivalent	Cionic
K202110	MStim Drop Model: LGT-233	Nov 05, 2021	Substantially Equivalent	Guangzhou Longest Science & Technology Co., Ltd.
K193276	Nerve and Muscle Stimulator	Sep 23, 2020	Substantially Equivalent	Shenzhen Xft Medical Limited
K200262	L100 Go System	Mar 04, 2020	Substantially Equivalent	Bioness, Inc.
K191587	L360 Thigh System	Sep 12, 2019	Substantially Equivalent	Bioness, Inc.
K190285	L300 Go System	Mar 14, 2019	Substantially Equivalent	Bioness, Inc.
K173682	L300 Go System	Mar 09, 2018	Substantially Equivalent	Bioness, Inc.
K171396	ODFS Pace XL	Jan 31, 2018	Substantially Equivalent	Odstock Medical, Ltd.
K162718	Foot Drop System (Model XFT-2001D)	Nov 30, 2017	Substantially Equivalent	Shenzhen Xft Medical Limited
K170564	MyndMove System, MyndMove Functional Electrical Stimulator	Aug 30, 2017	Substantially Equivalent	Myndtec, Inc.
K162470	RT300 FES cycle ergometer	Jul 11, 2017	Substantially Equivalent	Restorative Therapies, Inc.
K170132	MyoCycle Home, MyoCycle Pro	Apr 25, 2017	Substantially Equivalent	Myolyn, LLC
K162683	RehaStim 2	Feb 03, 2017	Substantially Equivalent	Hasomed GmbH
K162407	L300 Go System	Jan 27, 2017	Substantially Equivalent	Bioness, Inc.
K153163	ReGrasp	Apr 07, 2016	Substantially Equivalent	Rehabtronics, Inc.
K141812	MYGAIT STIMULATION SYSTEM	Apr 02, 2015	Substantially Equivalent	Otto Bock Healthcare Products GmbH
K140886	WALKAIDE SYSTEM	Aug 08, 2014	Substantially Equivalent	Innovative Neurotronics, Inc.
K131923	NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS	Jul 03, 2014	Substantially Equivalent	Techlink International
K132416	REHASTIM 2, ERIGOPRO (FES)	May 28, 2014	Substantially Equivalent	Hasomed GmbH
K123636	H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE	May 01, 2013	Substantially Equivalent	Bioness, Inc.
K123972	WALKAIDE SYSTEM	Apr 01, 2013	Substantially Equivalent	Innovative Neurotronics, Inc.
K122784	NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT	Dec 27, 2012	Substantially Equivalent	Bioness, Inc.
K120853	NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,	Apr 20, 2012	Substantially Equivalent	Bioness, Inc.
K112844	REHASTIM 2, REHAMOVE 2	Oct 27, 2011	Substantially Equivalent	Hasomed GmbH
K111767	NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT	Sep 15, 2011	Substantially Equivalent	Ness-Neuromuscular Electrical Stimulation Systems
K103343	L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)	Apr 29, 2011	Substantially Equivalent	Bioness, Inc.
K103370	RT200	Apr 05, 2011	Substantially Equivalent	Restorative Therapies, Inc.
K103366	RT600	Apr 04, 2011	Substantially Equivalent	Restorative Therapies, Inc.
K102115	ODFS PACE	Mar 30, 2011	Substantially Equivalent	Odstock Medical, Ltd.
K090750	RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581	Aug 05, 2009	Substantially Equivalent	Restorative Therapies, Inc.
K080219	MODIFICATION TO:NESS L300	Feb 28, 2008	Substantially Equivalent	Ness-Neuromuscular Electrical Stimulation Systems
K073237	REHASTIM & REHAMOVE	Dec 27, 2007	Substantially Equivalent	Hasomed GmbH
K072398	RT300-S AND RT300-SP FES CYCLE ERGOMETER	Nov 21, 2007	Substantially Equivalent	Restorative Therapies, Inc.
K071486	RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053	Sep 10, 2007	Substantially Equivalent	Restorative Therapies, Inc.
K071113	RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053	Jul 05, 2007	Substantially Equivalent	Restorative Therapies, Inc.
K053468	NESS L300	Jul 07, 2006	Substantially Equivalent	Ness-Neuromuscular Electrical Stimulation Systems
K060032	RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053	Mar 10, 2006	Substantially Equivalent	Restorative Therapies, Inc.
K052329	WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000	Sep 21, 2005	Substantially Equivalent	Innovative Neurotronics, Inc.
K050991	THE ODFS DROPPED FOOT STIMULATOR	Jul 15, 2005	Substantially Equivalent	Department of Medical Physics and Biomedical Eng.
K050036	FES CYCLE ERGOMETER, MODEL RT300-S	Jun 27, 2005	Substantially Equivalent	Restorative Therapies, Inc.
K031900	HANDMASTER	Aug 08, 2003	Substantially Equivalent	Ness-Neuromuscular Electrical Stimulation Systems
K012823	MODIFICATION TO HANDMASTER	Nov 14, 2001	Substantially Equivalent	Ness-Neuromuscular Electrical Stimulation Systems
K010837	HANDMASTER	Jun 15, 2001	Substantially Equivalent	Neuromusclar Electrical Stimulation Systems, Ltd.
K974514	EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR	Feb 06, 1998	Substantially Equivalent	Neuromotion, Inc.
K940759	FORTE ES	Mar 16, 1995	Substantially Equivalent	Chattanooga Group, Inc.
K911066	COMFORTRON PT (TENS)	Feb 07, 1992	Substantially Equivalent	M. D. Supply, Inc.
K912615	ROCHE COBAS ARGOS 5 DIFF	Sep 27, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K903434	SELECT NEUROMUSCULAR STIMULATORS	Aug 09, 1991	Substantially Equivalent	Medtronic Vascular
K873608	TENS LEAD	Sep 30, 1987	Substantially Equivalent	Desco Industries, Inc.
K813515	VERI/DFS TM #817	Jan 19, 1982	Substantially Equivalent	Verite
K800380	FES ORTHOSIS MODEL NO. 2000	Mar 17, 1980	Substantially Equivalent	Empi
K770987	NERVE STIMULATOR, MOLEL NO. FB-800	Jun 14, 1977	Substantially Equivalent	Output, Inc.
K770725	STIMULATOR, MUSCLE, MODEL 107	Apr 26, 1977	Substantially Equivalent	Jaytronics, Inc.