Regulatory Delimitation and Intended Use

(As of January 2026)

PROLAXsys® is a brand of Innosolution GmbH and stands for mechanical tools designed to support manual work.

The products do not constitute treatment concepts and have no medical intended purpose.

The devices are designed to enable controlled, precise and effort-efficient working and serve the mechanical support of manual working methods.

As non-medical products, PROLAXsys® devices offer clear advantages in everyday professional use:

greater flexibility in application

no medical application requirements or indications

no additional regulatory restrictions for users

The PROLAXsys® devices marketed by Innosolution GmbH as the manufacturer are mechanical vibration and massage tools intended exclusively for wellness, fitness, relaxation and other non-medical applications.

The products are not medical devices and are not intended for the diagnosis, treatment, alleviation, cure or prevention of diseases.

Applications with a medical, therapeutic, chiropractic or structurally corrective objective do not fall within the intended use of the devices.

Representations or applications by third parties that imply a medical use are carried out without the consent of Innosolution GmbH as the manufacturer and outside the scope of responsibility of the PROLAXsys® brand.

This distinction serves the clear and transparent classification of the products and is made in order to comply with the applicable regulatory requirements, including those fully effective as of 2027, regarding the separation of wellness products and medical devices.

Use of the devices is at the user’s own responsibility. The manufacturer assumes no liability, within the limits of the applicable legal provisions, for damages or disadvantages resulting from use outside the intended purpose.