GZJ · Class II · 21 CFR 882.5890

FDA Product Code GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Reliefband Technologies, LLC.

606
Total
606
Cleared
150d
Avg days
1976
Since
Growing category - 5 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 188d recently vs 149d historically

FDA 510(k) Cleared Stimulator, Nerve, Transcutaneous, For Pain Relief Devices (Product Code GZJ)

606 devices
1–24 of 606
Cleared May 28, 2026
STIMPOD NMS460 Nerve Stimulator
K252712
Algiamed Technologies USA, Inc.
Neurology · 274d
Cleared Jan 16, 2026
actiTENS mini
K252767
Sublimed
Neurology · 140d
Cleared Aug 15, 2025
CP Relief Wand Rx - TENS/NMES
K252236
N & C Holdings, LLC
Neurology · 29d
Cleared Aug 30, 2024
Unipro (K-UNIPRO-US)
K232441
Tenscare, Ltd.
Neurology · 382d
Cleared Aug 27, 2024
TENSWave
K241228
Zynex Medical Officer
Physical Medicine · 117d
Cleared Apr 19, 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046
Oriental Inspiration Limited
Neurology · 207d
Cleared Jan 24, 2023
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 124d
Cleared Sep 14, 2022
iRelieve Microcurrent Pain Relief System
K212618
Fast Track Technologies, Inc.
Neurology · 392d
Cleared Aug 26, 2022
StimOnTM Pain Relief System (GM2439)
K213802
Gimer Medical Co., Ltd.
Neurology · 263d
Cleared May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K220578
Bozhou Rongjian Medical Appliance Co., Ltd.
Neurology · 86d
Cleared Apr 23, 2022
TENS device-EmeTerm 2, Model: YF-ZTY-E2
K220503
Wat Medical Technology, Inc.
Neurology · 60d
Cleared Jun 18, 2021
Transcutaneous Electrical Nerve Stimulator
K202893
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology · 263d
Cleared Mar 23, 2021
TrueRelief Device
K202186
Truerelief
Neurology · 231d
Cleared Feb 24, 2021
BioWaveGO RX
K210202
Biowave Corporation
Neurology · 30d
Cleared Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
K201458
Delta International Services & Logistics S.R.L
Neurology · 205d
Cleared Dec 22, 2020
actiTENS
K202159
Sublimed
Neurology · 141d
Cleared Nov 09, 2020
OGYILI TENS/NMES Stimulator
K201431
Gongguan Tutamen Metalwork Co., Ltd.
Neurology · 161d
Cleared Aug 13, 2020
StimaWELL 120MTRS
K181645
Pierenkemper GmbH
Neurology · 783d
Cleared Aug 30, 2019
ReliefBand
K191547
Reliefband Technologies, LLC
Neurology · 79d
Cleared Jun 21, 2019
ReliefBand
K182960
Reliefband Technologies, LLC
Neurology · 239d
Cleared Jan 02, 2019
ClearUP Sinus Pain Relief
K182025
Tivic Health Systems, Inc.
Neurology · 156d
Cleared Aug 17, 2018
BioWaveGO
K180943
Biowave Corporation
Neurology · 129d
Cleared Apr 19, 2018
TENS device-EmeTerm, CinvStop
K172478
Wat Medical Technology (Ningbo) Co., Ltd.
Neurology · 246d
Cleared Dec 10, 1991
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963
Medtronic Vascular
Neurology · 222d

About Product Code GZJ - Regulatory Context

510(k) Submission Activity

606 total 510(k) submissions under product code GZJ since 1976, with 606 receiving FDA clearance (average review time: 150 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GZJ Product Code

Recent submissions under GZJ have taken an average of 188 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.

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