Technical Specifications of NeuroCes™
Powerful Technology, Safe to Use
NeuroCes™ combines advanced Cranial Electrotherapy Stimulation (CES) technology with a user-friendly and safe design. The device is developed according to the highest quality standards, offering a clinically proven treatment method while ensuring maximum safety in use.
Regulatory Compliance & Technical Description
Information on the compliance of the NeuroCes™ device with legal requirements in the European Union, as well as details about its technical specifications and features.
Applicable Regulations
In the member states of the European Union, devices for Cranial Electrotherapy Stimulation (CES) fall under the EU regulations for medical devices.
NeuroCes™ bears the CE marking as an active Class IIa medical device, certified by a Notified Body - the Slovenian Institute of Quality and Metrology (SIQ) - in accordance with the Medical Device Directive 93/42/EEC (MDD) and the Medical Device Regulation (EU) 2017/745 (MDR).
Device Description
Cranial Electrotherapy Stimulation is defined by FDA in its regulation (21 CFR 882.5800) as “a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety”.
NeuroCes™ is indicated for the treatment of anxiety, insomnia and depression. NeuroCes™ CES treatment has been available in doctor’s offices, clinics, and hospitals, and for home use. NeuroCes™ who draws advantages from the wealth of knowledge established over time has been designed to combine state-of-the-art technologies with advanced Cranial Electrotherapy Stimulation technique. The NeuroCes™ is a small and portable handheld battery powered medical device with a 1.8” LCD display, wire with touch proof socket for connecting to the ear clip electrodes and five control buttons.
Device Components
NeuroCes™ has three basic components. The first is the main unit that houses the electronics. This is responsible for generating the electrical stimulation that is delivered to the patient. This contains the controls with which the patient or physician can select the session time and adjust the stimulation intensity.
The second and third components are the Ear Clip Electrodes, which are clipped on the ear lobes and the Lead wire.
NeuroCes™ Main Unit
Ear Clip Electrode
Lead Wire
Technical Equipment
The compact design of NeuroCes™, combined with precise current settings and integrated software, provides an optimal and safe user experience.
Sizes: 115 x 68 x 22 mm
Weight: 155 g (with batteries)
Software: NeuroCes™ Embedded Software, Version 1.0.0
Device Common Name: Cranial Electrotherapy Stimulator (CES)
Batteries: 3 x AA 1.5 Volt Alkaline Batteries
Timer: 20, 40 or 60 minute countdown timers.
Current: 0 to 500 microamperes (μA) adjustable in 50 μA increments.
Frequency: 0.5 Hz (pulses per second).
Waveform: Square
Quality and Safety Standards
NeuroCes™ is designed and tested in compliance with international standards applicable to medical devices. The device meets all technical and regulatory requirements in key areas such as quality management, biocompatibility, risk assessment, software safety, and electromagnetic compatibility.
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes.
EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
EN ISO 14971
Medical devices - Application of risk management to medical devices
EN 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
EN 62304
Medical device software - Software life-cycle processes.