Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA product code GZJ · 599 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5890
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-30 – 2026-05-28

GZJ 2026-05-28

STIMPOD NMS460 Nerve Stimulator

Applicant Algiamed Technologies USA, Inc.

K number K252712

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GZJ 2026-01-16

actiTENS mini

Applicant Sublimed

K number K252767

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GZJ 2025-08-15

CP Relief Wand Rx - TENS/NMES

Applicant N & C Holdings, LLC

K number K252236

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GZJ 2024-08-30

Unipro (K-UNIPRO-US)

Applicant Tenscare, Ltd.

K number K232441

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GZJ 2024-08-27

TENSWave

Applicant Zynex Medical Officer

K number K241228

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GZJ 2024-04-19

Electrical Neuromuscular Stimulator, Cure Trio

Applicant Oriental Inspiration Limited

K number K233046

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GZJ 2023-01-24

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K222879

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GZJ 2022-09-14

iRelieve Microcurrent Pain Relief System

Applicant Fast Track Technologies, Inc.

K number K212618

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GZJ 2022-08-26

StimOnTM Pain Relief System (GM2439)

Applicant Gimer Medical Co., Ltd.

K number K213802

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GZJ 2022-05-25

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

Applicant Bozhou Rongjian Medical Appliance Co., Ltd.

K number K220578

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GZJ 2022-04-23

TENS device-EmeTerm 2, Model: YF-ZTY-E2

Applicant Wat Medical Technology, Inc.

K number K220503

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GZJ 2021-06-18

Transcutaneous Electrical Nerve Stimulator

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K202893

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GZJ 2021-03-23

TrueRelief Device

Applicant Truerelief

K number K202186

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GZJ 2021-02-24

BioWaveGO RX

Applicant Biowave Corporation

K number K210202

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GZJ 2020-12-23

Scrambler Therapy Technology (Model ST-5A)

Applicant Delta International Services & Logistics S.R.L

K number K201458

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GZJ 2020-12-22

actiTENS

Applicant Sublimed

K number K202159

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GZJ 2020-11-09

OGYILI TENS/NMES Stimulator

Applicant Gongguan Tutamen Metalwork Co., Ltd.

K number K201431

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GZJ 2020-08-13

StimaWELL 120MTRS

Applicant Pierenkemper GmbH

K number K181645

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GZJ 2019-08-30

ReliefBand

Applicant Reliefband Technologies, LLC

K number K191547

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GZJ 2019-06-21

ReliefBand

Applicant Reliefband Technologies, LLC

K number K182960

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GZJ 2019-01-02

ClearUP Sinus Pain Relief

Applicant Tivic Health Systems, Inc.

K number K182025

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GZJ 2018-08-17

BioWaveGO

Applicant Biowave Corporation

K number K180943

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GZJ 2018-04-19

TENS device-EmeTerm, CinvStop

Applicant Wat Medical Technology (Ningbo) Co., Ltd.

K number K172478

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GZJ 2017-11-30

ReliefBand 1.5

Applicant Reliefband Technologies

K number K173233

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GZJ 2017-01-18

STIMPOD NMS460 Nerve Stimulator

Applicant Xavant Technology (Pty), Ltd.

K number K161091

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GZJ 2017-01-17

WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

Applicant Well-Life Healthcare Limited

K number K162663

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GZJ 2016-10-06

SimulCare II(TM)

Applicant Xanacare Technologies, LLC

K number K160246

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GZJ 2016-06-03

Strive

Applicant Djo, LLC

K number K153704

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GZJ 2016-01-22

FD TENS 2090, FD TENS 2095

Applicant Fuji Dynamics , Ltd.

K number K152676

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GZJ 2013-10-28

JIAJIAN POINTOSELECT DIGITAL

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K123958

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GZJ 2013-07-02

SENSUS

Applicant Neurometrix, Inc.

K number K130919

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GZJ 2012-12-21

GEM-STIM COMBO STIMULATOR

Applicant Gemore Technology Co, Ltd.

K number K122948

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GZJ 2012-12-19

NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR

Applicant Ibramed Equipamentos Medicos

K number K121369

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GZJ 2012-09-25

STERLING MEDICAL IMPULSE 3 STIMULATOR

Applicant Armstrong Industries, Inc. Dha Mediquip Int. Dha S

K number K121305

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GZJ 2012-08-16

WITOUCH PRO

Applicant Hollywog, LLC

K number K120398

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GZJ 2012-08-02

SENSUS

Applicant Neurometrix, Inc.

K number K121184

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GZJ 2012-07-31

ATOM 1 (MODEL: BRC 2200)

Applicant Bioelectric Research Corporation

K number K121578

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GZJ 2012-07-27

ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER

Applicant Prospera Corporation

K number K113544

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GZJ 2012-07-20

GEMORE TENS SYSTEM

Applicant Gemore Technology Co, Ltd.

K number K120569

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GZJ 2012-06-05

ULTIMA NEO

Applicant Pain Management Technologies

K number K120054

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GZJ 2012-05-02

JIAJIAN TENS

Applicant Wuxi Jiajian Medical Instrument Co., Ltd.

K number K112288

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GZJ 2012-03-01

FD TENS 2070

Applicant Fuji Dynamics , Ltd.

K number K111654

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GZJ 2012-01-09

NEUROTECH PLUS

Applicant Bio-Medical Research, Ltd.

K number K112258

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GZJ 2011-12-06

H-WAVE

Applicant Electronic Waveform Lab, Inc.

K number K112485

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GZJ 2011-11-09

FD TENS 2050 OR SLIDE TENS MODEL FD2050

Applicant Fuji Dynamics , Ltd.

K number K111645

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GZJ 2011-10-20

QUADRA BLOC TENS PLUS

Applicant Gradient Technologies, LLC

K number K102278

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GZJ 2011-08-03

KNEEHAB XP

Applicant Bio-Medical Research, Ltd.

K number K110350

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GZJ 2011-07-29

ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR

Applicant Handelshaus Dittman GmbH

K number K110390

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GZJ 2010-12-08

NEMA-ST, MODEL V1.0.2

Applicant Nervomatrix, Ltd.

K number K100668

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GZJ 2010-08-31

TENS STIMULATOR, MODELS 2800 AND 3000

Applicant Koalaty Products, Inc.

K number K102014

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GZJ 2010-06-25

4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A

Applicant Well-Life Healthcare Limited

K number K100399

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GZJ 2010-05-28

SCENAR, MODEL 10

Applicant Ritm Okb Zao

K number K092117

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GZJ 2010-03-30

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2

Applicant Hivox Biotek, Inc.

K number K092448

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GZJ 2009-12-18

SMART TENS, MODEL: D-BC05T

Applicant Body Clock Health Care, Ltd.

K number K091045

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GZJ 2009-10-23

AMD 6605 TENS/NMES

Applicant Advantageous Medical Devices, LLC

K number K092990

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GZJ 2009-10-21

NEUROCALM MODEL 1 AND 2

Applicant Neuromed Devices, Inc.

K number K090866

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GZJ 2009-08-18

NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS

Applicant Aa Neuromed Corp.

K number K083250

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GZJ 2009-07-30

MANTRA COMBO, MODEL MECS 320

Applicant Mantra Intl. (Hk) , Ltd.

K number K091236

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GZJ 2009-06-25

LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK

Applicant Bio-Medical Research, Ltd.

K number K091317

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GZJ 2009-06-05

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR

Applicant Empi

K number K090922

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GZJ 2009-05-08

FLEX-TENS

Applicant Emsi

K number K090717

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GZJ 2009-05-06

LASER TOUCHONE

Applicant Laser Health Technologies, LLC

K number K083822

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GZJ 2009-03-19

ACTICARE IC AND TSE

Applicant Bioinduction Limited

K number K081835

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GZJ 2009-03-11

BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298

Applicant Bio-Medical Research, Ltd.

K number K082190

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GZJ 2009-02-26

DX6605E-TENS, DX6605E-G, DX6609-G

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K082057

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GZJ 2009-02-20

SCRAMBLER ST 5 TENS DEVICE

Applicant Competitive Technologies,Inc.

K number K081255

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GZJ 2009-02-09

TENSCARE ITOUCH MODEL(S) EASY AND PLUS

Applicant Tenscare, Ltd.

K number K082377

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GZJ 2009-02-05

TENS-EMS-14

Applicant Emsi

K number K083030

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GZJ 2009-01-06

ULTIMA FIVE

Applicant Pain Management Technologies

K number K083494

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GZJ 2008-12-15

COMBOCARE 2000

Applicant Xanacare Technologies, LLC

K number K083202

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GZJ 2008-11-28

MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458

Applicant Bio-Medical Research, Ltd.

K number K082011

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GZJ 2008-10-21

TENS/EMS COMBO, EMS, TENS

Applicant Medihightec Medical Co., Ltd.

K number K082514

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GZJ 2008-09-09

EA STIMULATOR

Applicant Helio Medical Supplies, Inc.

K number K080221

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GZJ 2008-08-29

COMBOCARE 2000

Applicant Xanacare Technologies, LLC

K number K081141

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GZJ 2008-06-20

PRO TENS, MODEL WL-240 RX

Applicant Well-Life Healthcare Limited

K number K080304

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GZJ 2008-03-13

AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999

Applicant Aemed, Inc.

K number K071120

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GZJ 2008-03-11

KFH ENERGY, MODEL: E1

Applicant Kingfisher Healthcare NV

K number K073008

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GZJ 2008-03-07

TENS/IF 14

Applicant Emsi

K number K071869

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GZJ 2008-02-07

PROSTIM 1000/2000

Applicant Bio Protech, Inc.

K number K073438

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GZJ 2008-02-01

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE

Applicant Biowave Corporation

K number K072123

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GZJ 2007-12-07

DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB

Applicant Med-Lectric Corporation

K number K071878

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GZJ 2007-11-27

EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR

Applicant Everlife Medical Equipment Co., Ltd.

K number K071624

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GZJ 2007-09-19

NEURO WAVE 6

Applicant Lhasa Oms, Inc.

K number K062003

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GZJ 2007-09-05

COMFY SERIES: EV-804, EV-805 & EV-806

Applicant Everyway Medical Instruments Co.,Ltd

K number K071951

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GZJ 2007-08-24

LORENZ BIOTECH APTIVA, VERSION 2.13

Applicant Lorenz Biotech S.P.A.

K number K061828

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GZJ 2007-07-16

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)

Applicant Ezfit Technology, Inc.

K number K070299

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GZJ 2007-07-06

WELLNESSPRO 2010

Applicant Intelsource Group, Inc.

K number K062616

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GZJ 2007-04-30

BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1

Applicant Avazzia, Inc.

K number K062641

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GZJ 2007-04-25

NEWLIFE SCIENCES LLC, MODEL TMR

Applicant Newlife Sciences, LLC

K number K070474

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GZJ 2007-03-21

QUADRA BLOC TENS, MODEL 101

Applicant Gradient Technologies, LLC

K number K062547

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GZJ 2007-02-13

BODIHEALTH SYSTEM

Applicant Usa Laser Therapeutics, Inc.

K number K052836

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GZJ 2007-02-06

STAODYN MAX PRESET, MODEL 4470

Applicant Compex Technologies, Inc.

K number K061516

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GZJ 2007-01-22

SELECT TENS, MODEL 4600S

Applicant Empi

K number K061650

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GZJ 2006-10-13

MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300

Applicant Healthonics, Inc.

K number K060669

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GZJ 2006-08-28

QUADRATENS, MODEL QT-42

Applicant Bio-Research Associates, Inc.

K number K061799

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GZJ 2006-07-26

ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1

Applicant Biomedical Life Systems, Inc.

K number K061476

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GZJ 2006-06-23

EMJOI TENS DEVICE

Applicant Emjoi, Inc.

K number K052711

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GZJ 2006-06-19

POINTER EXCEL

Applicant Lhasa Oms, Inc.

K number K060517

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GZJ 2006-06-19

POINTER PLUS

Applicant Lhasa Oms, Inc.

K number K060508

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GZJ 2006-05-05

INFREX

Applicant Johari Digital Healthcare , Ltd.

K number K060246

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