FDA Product Code
FDA Product Code GZJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5890
510(k) Clearances — 606 records · page 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026-05-28 | Traditional | PDF ↗ |
| K252767 | actiTENS mini | Sublimed | 2026-01-16 | Traditional | PDF ↗ |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025-08-15 | Special | PDF ↗ |
| K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024-08-30 | Traditional | PDF ↗ |
| K241228 | TENSWave | Zynex Medical Officer | 2024-08-27 | Abbreviated | PDF ↗ |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | Oriental Inspiration Limited | 2024-04-19 | Traditional | PDF ↗ |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2023-01-24 | Traditional | PDF ↗ |
| K212618 | iRelieve Microcurrent Pain Relief System | Fast Track Technologies, Inc. | 2022-09-14 | Traditional | PDF ↗ |
| K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022-08-26 | Traditional | PDF ↗ |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 | Traditional | PDF ↗ |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology, Inc. | 2022-04-23 | Traditional | PDF ↗ |
| K202893 | Transcutaneous Electrical Nerve Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-06-18 | Special | PDF ↗ |
| K202186 | TrueRelief Device | Truerelief | 2021-03-23 | Traditional | PDF ↗ |
| K210202 | BioWaveGO RX | Biowave Corporation | 2021-02-24 | Special | PDF ↗ |
| K201458 | Scrambler Therapy Technology (Model ST-5A) | Delta International Services & Logistics S.R.L | 2020-12-23 | Abbreviated | PDF ↗ |
| K202159 | actiTENS | Sublimed | 2020-12-22 | Traditional | PDF ↗ |
| K201431 | OGYILI TENS/NMES Stimulator | Gongguan Tutamen Metalwork Co., Ltd. | 2020-11-09 | Traditional | PDF ↗ |
| K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | 2020-08-13 | Traditional | PDF ↗ |
| K191547 | ReliefBand | Reliefband Technologies, LLC | 2019-08-30 | Special | PDF ↗ |
| K182960 | ReliefBand | Reliefband Technologies, LLC | 2019-06-21 | Special | PDF ↗ |
| K182025 | ClearUP Sinus Pain Relief | Tivic Health Systems, Inc. | 2019-01-02 | Traditional | PDF ↗ |
| K180943 | BioWaveGO | Biowave Corporation | 2018-08-17 | Traditional | PDF ↗ |
| K172478 | TENS device-EmeTerm, CinvStop | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-04-19 | Traditional | PDF ↗ |
| K173233 | ReliefBand 1.5 | Reliefband Technologies | 2017-11-30 | Traditional | PDF ↗ |
| K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017-01-18 | Traditional | PDF ↗ |
| K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | Well-Life Healthcare Limited | 2017-01-17 | Traditional | PDF ↗ |
| K160246 | SimulCare II(TM) | Xanacare Technologies, LLC | 2016-10-06 | Traditional | PDF ↗ |
| K153704 | Strive | Djo, LLC | 2016-06-03 | Abbreviated | PDF ↗ |
| K152676 | FD TENS 2090, FD TENS 2095 | Fuji Dynamics , Ltd. | 2016-01-22 | Traditional | PDF ↗ |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Biowave Corporation | 2015-09-25 | Special | PDF ↗ |
| K143198 | Synapse Transcutaneous Electrical Stimulation Device | Synapse Electroceutical Limited | 2015-05-27 | Traditional | PDF ↗ |
| K142666 | Scrambler Therapy MC-5 A Device | Delta International Services & Logistics S.R.L | 2015-05-22 | Traditional | PDF ↗ |
| K131513 | SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY | Ritm Okb Zao | 2014-07-11 | Traditional | PDF ↗ |
| K133779 | CP RELIEF WAND | Mid-America Medical Innovations, LLC | 2014-05-30 | Traditional | PDF ↗ |
| K123099 | Best-AV2 Pro-Sport(tm) | Avazzia, Inc. | 2014-05-23 | Traditional | PDF ↗ |
| K131675 | BODIHEALTH SYSTEM | Eprt Technologies, Inc. | 2014-03-12 | Special | PDF ↗ |
| K123958 | JIAJIAN POINTOSELECT DIGITAL | Wuxi Jiajian Medical Instrument Co., Ltd. | 2013-10-28 | Traditional | PDF ↗ |
| K130919 | SENSUS | Neurometrix, Inc. | 2013-07-02 | Traditional | PDF ↗ |
| K122948 | GEM-STIM COMBO STIMULATOR | Gemore Technology Co, Ltd. | 2012-12-21 | Special | PDF ↗ |
| K121369 | NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR | Ibramed Equipamentos Medicos | 2012-12-19 | Traditional | PDF ↗ |
| K121305 | STERLING MEDICAL IMPULSE 3 STIMULATOR | Armstrong Industries, Inc. Dha Mediquip Int. Dha S | 2012-09-25 | Traditional | PDF ↗ |
| K120398 | WITOUCH PRO | Hollywog, LLC | 2012-08-16 | Traditional | PDF ↗ |
| K121184 | SENSUS | Neurometrix, Inc. | 2012-08-02 | Traditional | PDF ↗ |
| K121578 | ATOM 1 (MODEL: BRC 2200) | Bioelectric Research Corporation | 2012-07-31 | Traditional | PDF ↗ |
| K113544 | ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER | Prospera Corporation | 2012-07-27 | Traditional | PDF ↗ |
| K120569 | GEMORE TENS SYSTEM | Gemore Technology Co, Ltd. | 2012-07-20 | Abbreviated | PDF ↗ |
| K120054 | ULTIMA NEO | Pain Management Technologies | 2012-06-05 | Abbreviated | PDF ↗ |
| K112288 | JIAJIAN TENS | Wuxi Jiajian Medical Instrument Co., Ltd. | 2012-05-02 | Traditional | PDF ↗ |
| K111654 | FD TENS 2070 | Fuji Dynamics , Ltd. | 2012-03-01 | Traditional | PDF ↗ |
| K112258 | NEUROTECH PLUS | Bio-Medical Research, Ltd. | 2012-01-09 | Traditional | PDF ↗ |
| K112485 | H-WAVE | Electronic Waveform Lab, Inc. | 2011-12-06 | Traditional | PDF ↗ |
| K111645 | FD TENS 2050 OR SLIDE TENS MODEL FD2050 | Fuji Dynamics , Ltd. | 2011-11-09 | Traditional | PDF ↗ |
| K102278 | QUADRA BLOC TENS PLUS | Gradient Technologies, LLC | 2011-10-20 | Traditional | PDF ↗ |
| K110350 | KNEEHAB XP | Bio-Medical Research, Ltd. | 2011-08-03 | Traditional | PDF ↗ |
| K110390 | ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR | Handelshaus Dittman GmbH | 2011-07-29 | Traditional | PDF ↗ |
| K100668 | NEMA-ST, MODEL V1.0.2 | Nervomatrix, Ltd. | 2010-12-08 | Traditional | PDF ↗ |
| K102014 | TENS STIMULATOR, MODELS 2800 AND 3000 | Koalaty Products, Inc. | 2010-08-31 | Traditional | PDF ↗ |
| K100399 | 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A | Well-Life Healthcare Limited | 2010-06-25 | Special | PDF ↗ |
| K092117 | SCENAR, MODEL 10 | Ritm Okb Zao | 2010-05-28 | Traditional | PDF ↗ |
| K092448 | HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 | Hivox Biotek, Inc. | 2010-03-30 | Traditional | PDF ↗ |
| K091045 | SMART TENS, MODEL: D-BC05T | Body Clock Health Care, Ltd. | 2009-12-18 | Traditional | PDF ↗ |
| K092990 | AMD 6605 TENS/NMES | Advantageous Medical Devices, LLC | 2009-10-23 | Traditional | PDF ↗ |
| K090866 | NEUROCALM MODEL 1 AND 2 | Neuromed Devices, Inc. | 2009-10-21 | Traditional | PDF ↗ |
| K083250 | NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS | Aa Neuromed Corp. | 2009-08-18 | Traditional | PDF ↗ |
| K091236 | MANTRA COMBO, MODEL MECS 320 | Mantra Intl. (Hk) , Ltd. | 2009-07-30 | Traditional | PDF ↗ |
| K091317 | LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK | Bio-Medical Research, Ltd. | 2009-06-25 | Special | PDF ↗ |
| K090922 | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR | Empi | 2009-06-05 | Special | PDF ↗ |
| K090717 | FLEX-TENS | Emsi | 2009-05-08 | Traditional | PDF ↗ |
| K083822 | LASER TOUCHONE | Laser Health Technologies, LLC | 2009-05-06 | Traditional | PDF ↗ |
| K081835 | ACTICARE IC AND TSE | Bioinduction Limited | 2009-03-19 | Traditional | PDF ↗ |
| K082190 | BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 | Bio-Medical Research, Ltd. | 2009-03-11 | Traditional | PDF ↗ |
| K082057 | DX6605E-TENS, DX6605E-G, DX6609-G | Shenzhen Dongdixin Technology Co., Ltd. | 2009-02-26 | Traditional | PDF ↗ |
| K081255 | SCRAMBLER ST 5 TENS DEVICE | Competitive Technologies,Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K082377 | TENSCARE ITOUCH MODEL(S) EASY AND PLUS | Tenscare, Ltd. | 2009-02-09 | Abbreviated | PDF ↗ |
| K083030 | TENS-EMS-14 | Emsi | 2009-02-05 | Traditional | PDF ↗ |
| K083494 | ULTIMA FIVE | Pain Management Technologies | 2009-01-06 | Traditional | PDF ↗ |
| K083202 | COMBOCARE 2000 | Xanacare Technologies, LLC | 2008-12-15 | Traditional | PDF ↗ |
| K082011 | MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 | Bio-Medical Research, Ltd. | 2008-11-28 | Traditional | PDF ↗ |
| K082514 | TENS/EMS COMBO, EMS, TENS | Medihightec Medical Co., Ltd. | 2008-10-21 | Traditional | PDF ↗ |
| K080221 | EA STIMULATOR | Helio Medical Supplies, Inc. | 2008-09-09 | Traditional | PDF ↗ |
| K081141 | COMBOCARE 2000 | Xanacare Technologies, LLC | 2008-08-29 | Traditional | PDF ↗ |
| K080304 | PRO TENS, MODEL WL-240 RX | Well-Life Healthcare Limited | 2008-06-20 | Traditional | PDF ↗ |
| K071120 | AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 | Aemed, Inc. | 2008-03-13 | Traditional | PDF ↗ |
| K073008 | KFH ENERGY, MODEL: E1 | Kingfisher Healthcare NV | 2008-03-11 | Traditional | PDF ↗ |
| K071869 | TENS/IF 14 | Emsi | 2008-03-07 | Traditional | PDF ↗ |
| K073438 | PROSTIM 1000/2000 | Bio Protech, Inc. | 2008-02-07 | Traditional | PDF ↗ |
| K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE | Biowave Corporation | 2008-02-01 | Traditional | PDF ↗ |
| K071878 | DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB | Med-Lectric Corporation | 2007-12-07 | Traditional | PDF ↗ |
| K071624 | EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR | Everlife Medical Equipment Co., Ltd. | 2007-11-27 | Traditional | PDF ↗ |
| K062003 | NEURO WAVE 6 | Lhasa Oms, Inc. | 2007-09-19 | Traditional | PDF ↗ |
| K071951 | COMFY SERIES: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007-09-05 | Special | PDF ↗ |
| K061828 | LORENZ BIOTECH APTIVA, VERSION 2.13 | Lorenz Biotech S.P.A. | 2007-08-24 | Traditional | PDF ↗ |
| K070299 | EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007-07-16 | Traditional | PDF ↗ |
| K062616 | WELLNESSPRO 2010 | Intelsource Group, Inc. | 2007-07-06 | Traditional | PDF ↗ |
| K062641 | BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 | Avazzia, Inc. | 2007-04-30 | Traditional | PDF ↗ |
| K070474 | NEWLIFE SCIENCES LLC, MODEL TMR | Newlife Sciences, LLC | 2007-04-25 | Traditional | PDF ↗ |
| K062547 | QUADRA BLOC TENS, MODEL 101 | Gradient Technologies, LLC | 2007-03-21 | Traditional | PDF ↗ |
| K052836 | BODIHEALTH SYSTEM | Usa Laser Therapeutics, Inc. | 2007-02-13 | Traditional | PDF ↗ |
| K061516 | STAODYN MAX PRESET, MODEL 4470 | Compex Technologies, Inc. | 2007-02-06 | Traditional | PDF ↗ |
| K061650 | SELECT TENS, MODEL 4600S | Empi | 2007-01-22 | Traditional | PDF ↗ |
Product code GZJ · Class II · Neurology. Data: openFDA.