Encephalic and peripheral nervous system devices
EMDN code N01
Manufacturers registered in Europe (EUDAMED) 47
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 276
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Drive Devilbiss Healthcare | United States | Roscoe Medical SuperStim Electrodes MultiStim Electrodes Richmar STICK-E-PADS LSI Silver Self Adhesive, Disposable Electrodes | registered |
| Rhythmlink International, LLC Present in Europe in other categories | United States | Rhythmlink® Rhythmlink RHYTHMLINK INTERNATIONAL, LLC MRQD42415 | K203079 (2021) |
| Technomed Engineering B.V. | – | Technomed Europe Cadwell Natus KING® Neuroguard CNS - Neuroguard | registered |
| Electro-Cap Intl., Inc. | United States | EAR ELEC3.5" DROPS EVOKED POTENTIAL CAP - LARGE NEURO-PULSE SYSTEM 2/CS2005 LEXICOR CAP-LARGE ELECTRO-CAP W/POZ-LARGE ORANGE STICKS | K112319 (2012) |
| Eemagine Medical Imaging Solutions GmbH Present in Europe in other categories | Germany | waveguard | K240575 (2024) |
| IMPULSE MEDICAL TECHNOLOGIES, INC. | – | The Electrode Store | registered |
| Shenzhen Yuwen E-Commerce Co., Ltd. | China | AUVON | registered |
| Emsi | United States | 40(16)HD TMR-ELEC-20352211 2 x 3.5 Foam Electrode TMR-ELEC-20404311 2 x 4 Oval Foam Electrode 25R(4)H-Samples TMR-GARM-GLOV9902000 TMR-ELEC-20402221 2 x 3.9 WH Electrode | K090889 (2009) |
| PRO MEDICAL SUPPLIES, INC. | China | ProPatch StimPatch EcoPatch FlexPlus ProMed Flex Plus | registered |
| PEPIN MANUFACTURING, INC. | – | AdvanTrode Freedom Stim Regentex | registered |
| DJO, LLC | United States | CHATTANOOGA COMPEX | registered |
| NATUS NEUROLOGY INCORPORATED Present in Europe in other categories | United States | Natus NATUS NEUROLOGY | registered |
| Willowwood Global LLC Present in Europe in other categories | United States | Alpha | registered |
| Infinite Biomedical Technologies, LLC Present in Europe in other categories | United States | Sense System with IBT Electrodes Glide Element System with IBT Electrodes | K240884 (2024) |
| Performance Health Supply Present in Europe in other categories | United States | Performance Health PERFORMA METRON | registered |
| LifeSync Corporation | United States | EverLast GoldSelect™ Rochester UltraLast GoldSelect NOISEFREE | registered |
| Ambu A/S Present in Europe in other categories | Denmark | Neuroline 720Neurology Surface Electrodes Neuroline 700Neurology Surface Electrodes Neuroline Cup Neuroline 710Neurology Surface Electrodes Neuroline 700 Neuroline GroundNeurology Surface Electrodes | K260578 (2026) |
| Chalgren Enterprises, Inc. | United States | Chalgren | K953356 (1996) |
| Everyway Medical Instruments Co.,Ltd | Taiwan | Everyway Pain Management Lifecare EVERYWAY4ALL MEDI-STIM | K173186 (2018) |
| Biomedical Life Systems, Inc. Present in Europe in other categories | United States | 2" x 2" pigtail electrode 2" round electrode BioDerm Adhesive Mounts 2" x 4" oval pigtail electrodes 3.75" x 6" butterfly electrode Conductive garment electrode glove lg. | registered |
| NEUROTRON MEDICAL, INC. | United States | PDC Restorer TheraKnit ReBuilder Medical Medical Science Products Relief Medical Pinnacle West Medical | K053214 (2005) |
| AXIOBIONICS | United States | BioGel Velcro Electrode UE BioSleeve LE BioSleeve BioBelt Ab BioMiniVest BioCollar | K141342 (2014) |
| BOXOUT, LLC | – | BodyMed Reserv TENSRX | registered |
| NATUS MANUFACTURING LIMITED Present in Europe in other categories | Ireland | Grass Grass® MR Conditional/CT Cup Electrodes Keypoint Natus | K242346 (2024) |
| COMPUMEDICS LIMITED Present in Europe in other categories | Australia | Compumedics Quik-Cap | registered |
| MEDIMAX TECH INC. | – | MediMax Tech | registered |
| Otto Bock Healthcare Products GmbH Present in Europe in other categories | Austria | Remote Electrode myosmart.cuff Myo Cuff myosmart trial kit Myo Plus TR Myo Plus trial kit | K253256 (2026) |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Cadwell Cadwell Single Disc Electrode Cadwell Bar Electrode Cadwell Ring Electrode Cadwell Disposable Tab Electrodes Cadwell Ground Plate Electrode | K261442 (2026) |
| Xi'an Friendship Medical Electronics Co.,Ltd. Present in Europe in other categories | China | Friendship Medical Cadwell | K110289 (2011) |
| Tensproducts, LLC | – | TENSPRODUCTS/TENSTRODE STIMWEAR StemWear TENSPRODUCTS | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Uni-Patch Kendall ComforEMS Plus ComforTENS Plus ComforEMS D ComforTENS D | registered |
| Columbia Scientific, Inc. | United States | Columbia Scientific | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | Uni-Patch Kendall | registered |
| XLTEK | Canada | Natus | registered |
| ALPHATEC SPINE, INC. | United States | SafeOp SafeOp 3 | registered |
| DYMEDIX DIAGNOSTICS, INC. Present in Europe in other categories | United States | Precision Gold Electrodes | K192564 (2020) |
| Motive Health, Inc. | United States | Motive Knee System QB1 NMES Electrode Set e-vive NMES Electrode Set CyMedica TENS Electrodes Set QB1 TENS Eletrode Set CyMedica e-vive™ NMES Electrode Set without Backings | registered |
| GRAPHIC CONTROLS ACQUISITION CORP | – | NeuroPlus™ PerformancePlus™ BioTens MVAP Medical Supplies DuraTENS Uroval Solid Gel Disposable Electrodes | registered |
| CLINICAL HEALTH SERVICES, INC. Present in Europe in other categories | – | Clinical Health Services, Inc. Therapist’s Choice® Therapist's Choice | registered |
| Bio Medical Innovations | – | BF-3 TPWT4-3 TPWT4-5 BF-2 TPWT4-2 BF-4 | registered |
| Interacoustics A/S Present in Europe in other categories | Denmark | Sanibel Sanibel Supply Sanibel Supply A/S | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Pro Advantage | registered |
| South Dakota Partners Inc. | United States | Richmar | K223775 (2023) |
| TRUMEDICAL SOLUTIONS, LLC | United States | Tru Mediflex | registered |
| g.tec medical engineering GmbH Present in Europe in other categories | Austria | g.Nautilus PRO | registered |
| Dynatronics Corp. | United States | DynaFlex (Foam) 2"x3.5" DynaFlex Brown 2"x2" DynaFlex 2"x2" Square Snap DynaFlex (Foam) 2"x2" DynaFlex 2"x2" DynaFlex 2" Round | K132057 (2014) |
| PAMEL d.o.o. Present in Europe in other categories | Croatia | COMBY EEG CAP | K211315 (2021) |
| NORTH COAST MEDICAL, INC. Present in Europe in other categories | United States | Norco Multi-Use Electrode, Foam Norco Multi-Use Electrode, Cloth | registered |
| Prizm Medical, Inc. | United States | Electro-Mesh Panel Electro-Mesh Glove Silver-Thera Sock Intelligent Textile Stim-Support Back Wrap Stim-Support Shoulder Brace Stim-Support Elbow Brace | K944487 (1995) |
| UAN HEALTHCARE LIMITED | – | AUVON | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | Vive | registered |
| Biowave Corporation | United States | BioWave Silver Back BioWrap S/M BioWave BLUE Back BioWrap S/M BioWave Silver Foot-Ankle BioWrap S/M BioWave BLUE Knee BioWrap L/XL BioWave Silver Knee BioWrap L/XL BioWave BLUE Knee BioWrap S/M | K261522 (2026) |
| MEDTRONIC SOFAMOR DANEK, INC. Present in Europe in other categories | United States | – | registered |
| Neurometrix, Inc. | United States | QUELL FIBROMYALGIA QUELL Quell Electrode | K140586 (2014) |
| Pain Management Technologies | United States | soft-touch iTENS | K030375 (2003) |
| Rs Medical | United States | RS Medical RS-LB Low Back Conductive Garment RS-LBG Low Back Garment RS-CFBG Conductive Full Back Garment RS-FBG Full Back Conductive Garment RS-FBG-O Full Back Garment Only | K090951 (2009) |
| Shenzhen roundwhale technology co. LTD. Present in Europe in other categories | China | ROOVJOY | K232995 (2024) |
| Coapt, LLC | United States | ControlSeal Electrode Domes (Standard Size) ControlSeal Electrode Domes (Large Size) Complete Communicator Complete Controller Complete Calibrate Dome Electrodes | K223738 (2023) |
| Conmed Corporation Present in Europe in other categories | United States | BRAINSTREAM | K200540 (2020) |
| Guangzhou Xinbo Electronic Co., Ltd. Present in Europe in other categories | China | DR -HOS | K231167 (2023) |
| Lkc Technologies, Inc. | United States | RETeval™ RETeval | registered |
| Zeto, Inc. | United States | Zeto ONE EMG Cable Extension Set Zeto ONE HEOG Cable Extension Set Zeto ONE Short-Term Electrode Set Zeto ONE REF Cable Extension Soft Flex-M Zeto ONE Electrode Set — Basic | registered |
| Cathay Manufacturing Corp. Present in Europe in other categories | China | Cathay | K160081 (2016) |
| Hi-Dow International Incorporated | United States | HiDow | K210383 (2021) |
| A. R. DAVIS COMPANY, INC. | – | Excel Plus Excel CF | registered |
| Clearlake-Tech Inc. Present in Europe in other categories | United States | Richmar | registered |
| Neurovirtual USA, Inc. Present in Europe in other categories | United States | Neurovirtual | K163547 (2017) |
| PHYSIO TECH INC. | – | Physiotrode EcoTrode | registered |
| SME, INC. USA | – | SME | registered |
| VERIDIAN HEALTHCARE LLC | – | Zewa VERIDIAN | registered |
| ACCELERATED CARE PLUS CORP | United States | OmniVersa High Conductivity Electrodes ACP High Conductivity Electrodes 4x4 electrodes ACP High Conductivity Electrodes 2X2 Synchrony Dysphagia Solutions by ACP Synchrony Face & Neck PENS Electrode ACP High Conductivity Electrodes 3x5 | registered |
| BIONIT LABS SRL Present in Europe in other categories | Italy | Remote Wave Electrode Wave Electrode with accessories Wave Electrode | K260453 (2026) |
| BIOSERENITY MEDICAL DEVICES GROUP Present in Europe in other categories | France | Neuronaute IceCap 2 Neuronaute® IceCap Neonate (XS) Neuronaute Touchproof Adapter Neuronaute® IceCap Neonate (S) Neuronaute - IceAdapter Neuronaute IceCap 2 Small | K243788 (2025) |
| Bio-Medical Research, Ltd. | Ireland | Slendertone Replacement Abdominal Toning Gel Pads Face Gel Pads Slendertone Replacement Bottom Toning Gel Pads Slendertone Unisex Replacement Gel Pads for Revive S5 Slendertone Replacement Bottom and Thigh Toning Pads Slendertone Arm Toner Muscle Training System Gel Pads | K112934 (2012) |
| SAUVRE INTERNATIONAL, LTD. | – | Medical Science Products EASLIEF | registered |
| BEAR DOWN CONSULTING | – | PURE ENRICHMENT | registered |
| C.M.P. Canadian Medical Products Inc | Canada | C.M.P. Cable ProFlex ProCarbon | registered |
| EXCELHEALTH, INC. | – | iReliev | registered |
| Epitel, Inc. | United States | REMI | registered |
| FIAB SPA Present in Europe in other categories | Italy | – | K091163 (2009) |
| HTK ENTERPRISES, INC. | – | InterX | registered |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | – | registered |
| Mettler Electronics Corp. | United States | EZ Trode, 2" x 5" rectangular V Trode, 2" round EZ Trode, 2.75" round V Trode, 2.75" round EZ Trode, 2" round EZ Trode, 2" square | registered |
| Shenzhen Changke Connect Electronics Co., Ltd. Present in Europe in other categories | China | Changke Connect | K213884 (2022) |
| WAVI CO. | United States | WAVi Co. WAVi Style Ear Clips WAVi Co WAVi Scan Kit | K162460 (2017) |
| Zimmer Medizinsysteme GmbH Present in Europe in other categories | Germany | Zimmertrodes | registered |
| ALIMED, INC. | United States | ProStim Electrodes | registered |
| Covidien, LLC Present in Europe in other categories | United States | BIS | K143506 (2015) |
| ZMI ELECTRONICS LTD. Present in Europe in other categories | Taiwan | ZMI PowerDot | K180865 (2018) |
| EASY HEALTHCARE CORPORATION | – | Easy@Home Adhesive Electrodes Easy@Home Self-Adhesive Reusable Electrodes Easy@Home Adhesive Electrode Pads | registered |
| Innovative Neurotronics, Inc. | United States | WalkAide WalkAide 1.25 Premium Electrodes - pkg of 4 WalkAide 1.875 Premium Electrodes - pkg of 4 WalkAide Electrodes - package of 4 | registered |
| Ives Eeg Solutions, Inc. | Canada | Ives EEG Solutions | K071118 (2007) |
| PLAYMAKAR INC. | United States | PlayMakar | registered |
| Scriphessco | – | Scrip Hessco | registered |
| Shenzhen Damiti Technology Co., Ltd. | – | Pohaku | registered |
| ADP HEALTH LIMITED | – | AVCOO AVCOO Adhesive Electrodes | registered |
| BEURER NORTH AMERICA, L.P. | – | Beurer Vitalcontrol | registered |
| Etymotic Research | United States | Etymotic Research Etymotic | K873298 (1987) |
| INCEREB LIMITED | Ireland | neon12 neon8 N10 NeuroBell Neon8 KIT Neon 12 KIT | K151576 (2015) |
The 100 most active manufacturers are shown, out of 276.
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