GZI · Class II · 21 CFR 882.5810

FDA Product Code GZI: Stimulator, Neuromuscular, External Functional

Leading manufacturers include Bioness, Inc., Restorative Therapies, Inc. and Hasomed GmbH.

61
Total
61
Cleared
153d
Avg days
1977
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 223d recently vs 149d historically

FDA 510(k) Cleared Stimulator, Neuromuscular, External Functional Devices (Product Code GZI)

61 devices
1–24 of 61
Cleared Jun 05, 2025
Synchrony (20-3000)
K242704
Synapse Biomedical, Inc.
Neurology · 269d
Cleared May 02, 2025
CIONIC NEURAL SLEEVE (NS-200)
K243828
Cionic, Inc.
Physical Medicine · 140d
Cleared Nov 22, 2024
Neuvotion NeuStim NN-01
K240632
Neuvotion, Inc.
Neurology · 261d
Cleared Jun 25, 2024
MyndMove, MyndMove 2.0
K233006
Myndtec, Inc.
Physical Medicine · 277d
Cleared Dec 28, 2023
EvoWalk 1.0 System
K230997
Evolution Devices, Inc.
Neurology · 265d
Cleared Jul 21, 2022
Cionic Neural Sleeve NS-100
K221823
Cionic
Physical Medicine · 28d
Cleared Apr 25, 2022
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
K213925
Myolyn, LLC
Neurology · 130d
Cleared Mar 03, 2022
MyndMove 2.0
K212149
Myndtec, Inc.
Physical Medicine · 237d
Cleared Feb 14, 2022
Cionic Neural Sleeve NS-100
K213622
Cionic
Neurology · 90d
Cleared Nov 05, 2021
MStim Drop Model: LGT-233
K202110
Guangzhou Longest Science & Technology Co., Ltd.
Neurology · 463d
Cleared Sep 23, 2020
Nerve and Muscle Stimulator
K193276
Shenzhen Xft Medical Limited
Neurology · 302d
Cleared Mar 04, 2020
L100 Go System
K200262
Bioness, Inc.
Neurology · 30d
Cleared Sep 12, 2019
L360 Thigh System
K191587
Bioness, Inc.
Neurology · 90d
Cleared Mar 14, 2019
L300 Go System
K190285
Bioness, Inc.
Neurology · 31d
Cleared Mar 09, 2018
L300 Go System
K173682
Bioness, Inc.
Neurology · 98d
Cleared Jan 31, 2018
ODFS Pace XL
K171396
Odstock Medical, Ltd.
Neurology · 265d
Cleared Nov 30, 2017
Foot Drop System (Model XFT-2001D)
K162718
Shenzhen Xft Medical Limited
Neurology · 427d
Cleared Aug 30, 2017
MyndMove System, MyndMove Functional Electrical Stimulator
K170564
Myndtec, Inc.
Neurology · 184d
Cleared Jul 11, 2017
RT300 FES cycle ergometer
K162470
Restorative Therapies, Inc.
Neurology · 308d
Cleared Apr 25, 2017
MyoCycle Home, MyoCycle Pro
K170132
Myolyn, LLC
Neurology · 98d
Cleared Feb 03, 2017
RehaStim 2
K162683
Hasomed GmbH
Neurology · 130d
Cleared Jan 27, 2017
L300 Go System
K162407
Bioness, Inc.
Neurology · 151d
Cleared Apr 07, 2016
ReGrasp
K153163
Rehabtronics, Inc.
Neurology · 157d
Cleared Apr 02, 2015
MYGAIT STIMULATION SYSTEM
K141812
Otto Bock Healthcare Products GmbH
Neurology · 269d

About Product Code GZI - Regulatory Context

510(k) Submission Activity

61 total 510(k) submissions under product code GZI since 1977, with 61 receiving FDA clearance (average review time: 153 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GZI Product Code

Recent submissions under GZI have taken an average of 223 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.

GZI devices are reviewed by the Neurology panel. Browse all Neurology devices →