Atlas FDA

GZJ

606 FDA 510(k) clearances · Product code

112 daysmedian time to decision
311 days90th percentile
606clearances measured

FDA profile

Official device name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2014: 23 · 2015: 18 · 2016: 32 · 2017: 58 · 2018: 21 · 2023: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
STIMPOD NMS460 Nerve Stimulator (K252712)Algiamed Technologies USA, Inc.2026-05-28
actiTENS mini (K252767)Sublimed2026-01-16
CP Relief Wand Rx - TENS/NMES (K252236)N & C Holdings, LLC2025-08-15
Unipro (K-UNIPRO-US) (K232441)Tenscare, Ltd.2024-08-30
TENSWave (K241228)Zynex Medical Officer2024-08-27
Electrical Neuromuscular Stimulator, Cure Trio (K233046)Oriental Inspiration Limited2024-04-19
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (K222879)Wuxi Jiajian Medical Instrument Co., Ltd.2023-01-24
iRelieve Microcurrent Pain Relief System (K212618)Fast Track Technologies, Inc.2022-09-14
StimOnTM Pain Relief System (GM2439) (K213802)Gimer Medical Co., Ltd.2022-08-26
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (K220578)Bozhou Rongjian Medical Appliance Co., Ltd.2022-05-25
TENS device-EmeTerm 2, Model: YF-ZTY-E2 (K220503)Wat Medical Technology, Inc.2022-04-23
Transcutaneous Electrical Nerve Stimulator (K202893)Wuxi Jiajian Medical Instrument Co., Ltd.2021-06-18
TrueRelief Device (K202186)Truerelief2021-03-23
BioWaveGO RX (K210202)Biowave Corporation2021-02-24
Scrambler Therapy Technology (Model ST-5A) (K201458)Delta International Services & Logistics S.R.L2020-12-23
actiTENS (K202159)Sublimed2020-12-22
OGYILI TENS/NMES Stimulator (K201431)Gongguan Tutamen Metalwork Co., Ltd.2020-11-09
StimaWELL 120MTRS (K181645)Pierenkemper GmbH2020-08-13
ReliefBand (K191547)Reliefband Technologies, LLC2019-08-30
ReliefBand (K182960)Reliefband Technologies, LLC2019-06-21
ClearUP Sinus Pain Relief (K182025)Tivic Health Systems, Inc.2019-01-02
BioWaveGO (K180943)Biowave Corporation2018-08-17
TENS device-EmeTerm, CinvStop (K172478)Wat Medical Technology (Ningbo) Co., Ltd.2018-04-19
ReliefBand 1.5 (K173233)Reliefband Technologies2017-11-30
STIMPOD NMS460 Nerve Stimulator (K161091)Xavant Technology (Pty), Ltd.2017-01-18
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A (K162663)Well-Life Healthcare Limited2017-01-17
SimulCare II(TM) (K160246)Xanacare Technologies, LLC2016-10-06
Strive (K153704)Djo, LLC2016-06-03
FD TENS 2090, FD TENS 2095 (K152676)Fuji Dynamics , Ltd.2016-01-22
BiowaveHOME Neuromodulation Pain Therapy Device (K152437)Biowave Corporation2015-09-25
Synapse Transcutaneous Electrical Stimulation Device (K143198)Synapse Electroceutical Limited2015-05-27
Scrambler Therapy MC-5 A Device (K142666)Delta International Services & Logistics S.R.L2015-05-22
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY (K131513)Ritm Okb Zao2014-07-11
CP RELIEF WAND (K133779)Mid-America Medical Innovations, LLC2014-05-30
Best-AV2 Pro-Sport(tm) (K123099)Avazzia, Inc.2014-05-23
BODIHEALTH SYSTEM (K131675)Eprt Technologies, Inc.2014-03-12
JIAJIAN POINTOSELECT DIGITAL (K123958)Wuxi Jiajian Medical Instrument Co., Ltd.2013-10-28
SENSUS (K130919)Neurometrix, Inc.2013-07-02
GEM-STIM COMBO STIMULATOR (K122948)Gemore Technology Co, Ltd.2012-12-21
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR (K121369)Ibramed Equipamentos Medicos2012-12-19
STERLING MEDICAL IMPULSE 3 STIMULATOR (K121305)Armstrong Industries, Inc. Dha Mediquip Int. Dha S2012-09-25
WITOUCH PRO (K120398)Hollywog, LLC2012-08-16
SENSUS (K121184)Neurometrix, Inc.2012-08-02
ATOM 1 (MODEL: BRC 2200) (K121578)Bioelectric Research Corporation2012-07-31
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER (K113544)Prospera Corporation2012-07-27
GEMORE TENS SYSTEM (K120569)Gemore Technology Co, Ltd.2012-07-20
ULTIMA NEO (K120054)Pain Management Technologies2012-06-05
JIAJIAN TENS (K112288)Wuxi Jiajian Medical Instrument Co., Ltd.2012-05-02
FD TENS 2070 (K111654)Fuji Dynamics , Ltd.2012-03-01
NEUROTECH PLUS (K112258)Bio-Medical Research, Ltd.2012-01-09
H-WAVE (K112485)Electronic Waveform Lab, Inc.2011-12-06
FD TENS 2050 OR SLIDE TENS MODEL FD2050 (K111645)Fuji Dynamics , Ltd.2011-11-09
QUADRA BLOC TENS PLUS (K102278)Gradient Technologies, LLC2011-10-20
KNEEHAB XP (K110350)Bio-Medical Research, Ltd.2011-08-03
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR (K110390)Handelshaus Dittman GmbH2011-07-29
NEMA-ST, MODEL V1.0.2 (K100668)Nervomatrix, Ltd.2010-12-08
TENS STIMULATOR, MODELS 2800 AND 3000 (K102014)Koalaty Products, Inc.2010-08-31
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A (K100399)Well-Life Healthcare Limited2010-06-25
SCENAR, MODEL 10 (K092117)Ritm Okb Zao2010-05-28
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 (K092448)Hivox Biotek, Inc.2010-03-30
SMART TENS, MODEL: D-BC05T (K091045)Body Clock Health Care, Ltd.2009-12-18
AMD 6605 TENS/NMES (K092990)Advantageous Medical Devices, LLC2009-10-23
NEUROCALM MODEL 1 AND 2 (K090866)Neuromed Devices, Inc.2009-10-21
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS (K083250)Aa Neuromed Corp.2009-08-18
MANTRA COMBO, MODEL MECS 320 (K091236)Mantra Intl. (Hk) , Ltd.2009-07-30
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK (K091317)Bio-Medical Research, Ltd.2009-06-25
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR (K090922)Empi2009-06-05
FLEX-TENS (K090717)Emsi2009-05-08
LASER TOUCHONE (K083822)Laser Health Technologies, LLC2009-05-06
ACTICARE IC AND TSE (K081835)Bioinduction Limited2009-03-19
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 (K082190)Bio-Medical Research, Ltd.2009-03-11
DX6605E-TENS, DX6605E-G, DX6609-G (K082057)Shenzhen Dongdixin Technology Co., Ltd.2009-02-26
SCRAMBLER ST 5 TENS DEVICE (K081255)Competitive Technologies,Inc.2009-02-20
TENSCARE ITOUCH MODEL(S) EASY AND PLUS (K082377)Tenscare, Ltd.2009-02-09
TENS-EMS-14 (K083030)Emsi2009-02-05
ULTIMA FIVE (K083494)Pain Management Technologies2009-01-06
COMBOCARE 2000 (K083202)Xanacare Technologies, LLC2008-12-15
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 (K082011)Bio-Medical Research, Ltd.2008-11-28
TENS/EMS COMBO, EMS, TENS (K082514)Medihightec Medical Co., Ltd.2008-10-21
EA STIMULATOR (K080221)Helio Medical Supplies, Inc.2008-09-09
COMBOCARE 2000 (K081141)Xanacare Technologies, LLC2008-08-29
PRO TENS, MODEL WL-240 RX (K080304)Well-Life Healthcare Limited2008-06-20
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 (K071120)Aemed, Inc.2008-03-13
KFH ENERGY, MODEL: E1 (K073008)Kingfisher Healthcare NV2008-03-11
TENS/IF 14 (K071869)Emsi2008-03-07
PROSTIM 1000/2000 (K073438)Bio Protech, Inc.2008-02-07
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE (K072123)Biowave Corporation2008-02-01
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB (K071878)Med-Lectric Corporation2007-12-07
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR (K071624)Everlife Medical Equipment Co., Ltd.2007-11-27
NEURO WAVE 6 (K062003)Lhasa Oms, Inc.2007-09-19
COMFY SERIES: EV-804, EV-805 & EV-806 (K071951)Everyway Medical Instruments Co.,Ltd2007-09-05
LORENZ BIOTECH APTIVA, VERSION 2.13 (K061828)Lorenz Biotech S.P.A.2007-08-24
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) (K070299)Ezfit Technology, Inc.2007-07-16
WELLNESSPRO 2010 (K062616)Intelsource Group, Inc.2007-07-06
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 (K062641)Avazzia, Inc.2007-04-30
NEWLIFE SCIENCES LLC, MODEL TMR (K070474)Newlife Sciences, LLC2007-04-25
QUADRA BLOC TENS, MODEL 101 (K062547)Gradient Technologies, LLC2007-03-21
BODIHEALTH SYSTEM (K052836)Usa Laser Therapeutics, Inc.2007-02-13
STAODYN MAX PRESET, MODEL 4470 (K061516)Compex Technologies, Inc.2007-02-06
SELECT TENS, MODEL 4600S (K061650)Empi2007-01-22
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