FDA Product Code GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief
Leading manufacturers include Biomedical Life Systems, Inc., Empi and Medical Devices, Inc..
606
Total
606
Cleared
150d
Avg days
1976
Since
Declining activity -
3 submissions in the last 2 years
vs 4 in the prior period
Consistent review times:
148d avg (recent)
FDA 510(k) Cleared Stimulator, Nerve, Transcutaneous, For Pain Relief Devices (Product Code GZJ)
606 devices
Cleared
May 28, 2026
STIMPOD NMS460 Nerve Stimulator
Algiamed Technologies USA, Inc.
Neurology
274d
Cleared
Jan 16, 2026
actiTENS mini
Sublimed
Neurology
140d
Cleared
Aug 15, 2025
CP Relief Wand Rx - TENS/NMES
N & C Holdings, LLC
Neurology
29d
Cleared
Aug 30, 2024
Unipro (K-UNIPRO-US)
Tenscare, Ltd.
Neurology
382d
Cleared
Aug 27, 2024
TENSWave
Zynex Medical Officer
Physical Medicine
117d
Cleared
Apr 19, 2024
Electrical Neuromuscular Stimulator, Cure Trio
Oriental Inspiration Limited
Neurology
207d
Cleared
Jan 24, 2023
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology
124d
Cleared
Sep 14, 2022
iRelieve Microcurrent Pain Relief System
Fast Track Technologies, Inc.
Neurology
392d
Cleared
Aug 26, 2022
StimOnTM Pain Relief System (GM2439)
Gimer Medical Co., Ltd.
Neurology
263d
Cleared
May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Bozhou Rongjian Medical Appliance Co., Ltd.
Neurology
86d
Cleared
Apr 23, 2022
TENS device-EmeTerm 2, Model: YF-ZTY-E2
Wat Medical Technology, Inc.
Neurology
60d
Cleared
Jun 18, 2021
Transcutaneous Electrical Nerve Stimulator
Wuxi Jiajian Medical Instrument Co., Ltd.
Neurology
263d
Cleared
Mar 23, 2021
TrueRelief Device
Truerelief
Neurology
231d
Cleared
Feb 24, 2021
BioWaveGO RX
Biowave Corporation
Neurology
30d
Cleared
Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
Delta International Services & Logistics S.R.L
Neurology
205d
Cleared
Dec 22, 2020
actiTENS
Sublimed
Neurology
141d
Cleared
Nov 09, 2020
OGYILI TENS/NMES Stimulator
Gongguan Tutamen Metalwork Co., Ltd.
Neurology
161d
Cleared
Aug 13, 2020
StimaWELL 120MTRS
Pierenkemper GmbH
Neurology
783d
Cleared
Aug 30, 2019
ReliefBand
Reliefband Technologies, LLC
Neurology
79d
Cleared
Jun 21, 2019
ReliefBand
Reliefband Technologies, LLC
Neurology
239d
Cleared
Jan 02, 2019
ClearUP Sinus Pain Relief
Tivic Health Systems, Inc.
Neurology
156d
Cleared
Aug 17, 2018
BioWaveGO
Biowave Corporation
Neurology
129d
Cleared
Apr 19, 2018
TENS device-EmeTerm, CinvStop
Wat Medical Technology (Ningbo) Co., Ltd.
Neurology
246d
Cleared
Nov 30, 2017
ReliefBand 1.5
Reliefband Technologies
Neurology
56d
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 declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - GZJ Product Code
FDA review times for GZJ submissions have been consistent, averaging 148 days recently vs 150 days historically.
GZJ devices are reviewed by the Neurology panel. Browse all Neurology devices →