20 September 2023
New evolutionary step of KARNAK® and UNIWAVE® wellness devices
New EU directive 2017/745 gives us the opportunity for technological advancement
New EU directive 2017/745 gives us the opportunity for technological advancement.
Recently, the European Commission has placed great interest in devices that stimulate neurons using TMS (Transcranial Magnetic Stimulation). This has resulted in any device using this technique, regardless of therapeutic or nontherapeutic function, being included in the new EU Regulation 2017/745 dedicated to medical devices.
KARNAK® has always been a precursor of low-intensity and low-frequency electromagnetic stimulation that interacts and tunes-up the emissions of the generated frequency signals of brain areas and cells. Having been the pioneers of this technology, patented since 1991, and initially dedicated only to the domestic and professional non-therapeutic field, we cannot avoid the great opportunity given by the most recent EU 2022/2347 and EU 2023/607 executive regulations.
It is with great satisfaction that we learn of the European Commission's considerable interest in the TMS technology field, a technology that we have built and developed over the course of more than 30 years. A path of continuous evolution affirmed by as many as 7 Italian and international patents in PEMF and TMS specific technology with the achievement of class IIa medical certifications since the year 2015.
Update June 22, 2023:The European Commission through Implementing Regulation (EU) 2023/1194 of June 20, 2023 changed the implementation date of the transitional provisions to January 1, 2027 for devices in Annex XVI that apply the principles of transcranial magnetic stimulation for neuronal interaction.
Therefore, the coded project "LIFE PULSE" will be remodeled on the new planned date of January 1, 2027, and will cover pulsed electromagnetic stimulation applied to both living and nonliving matter, the latter having its own electromagnetic vibration and with water as its fundamental element.
KARNAK® Professional Wellness Line and UNIWAVE® Home Wellness Line devices are back available for online purchase and order through the website, in accordance with executive regulations.