Scheduled Routine Maintenance for the customized insole

Many regulations like DL 46/97 art.10 (and additions), UNI CEI EN ISO 14971 art. 9, and  ISO 9001 ISO 13485, obligate the producer of medical devices to offer an after-sales Scheduled Routine Maintenance in order to make sure that the device is still suitable for the purpose it has been produced for and that no risk emerged for the final user.

Considering what above, it is in the interest of the patient to attend all the Scheduled Routine Maintenance, following the timing indicated in the “Scheduled Routine Maintenance table”.

It is responsibility of the patient to call our office to book an appointment in our laboratory.

  • 1st check-up within 25 days
  • 2nd check-up within 90 days from the previous one
  • 3rd check-up within 90 days from the previous one
  • Further check-ups every 90 days


Dear Valued customer,

thanks for choosing TONUS Foot laboratory. The trust received from you brings us to work with renew enthusiasm in order to create new products and to keep improving our services, to achieve your satisfaction and to guarantee higher standards of Safety and Performance.

For this reason we create for you our after-sales service.



This service aims to solve the smaller or bigger problems that might happen after the delivery of the insole:

  • after wearing the insole for few days / hours, and gradually increasing the time of use, a spot on my foot gets red and/or hurts
  • The footwear used together with the insole is pushing against some parts of my foot causing redness
  • while using the insole I feel pain on my thighs and/or calves and/or back etc.
  • any other pain or discomfort


What to do

Please call us immediately to receive information and assistance. Sometimes our phone operator might be able to solve the issue but sometimes the assistance of a TONUS Orthopedic technician is required.

In case we will not be able to pick up your call immediately, your data will be collected and we will get in touch with you as soon as possible.

Our after-sales service includes also the correction required after the initial trial, like for instance the ones indicated by the doctor.

We highly recommend to attend all the scheduled routine maintenance even if you are not experiencing any discomfort to avoid any issues connected to the wear of the insole.


What is not included in the cost of the insole?

Extraordinary corrections caused by the usage of the insole and/or to the improper use of if are not included in the cost of the insole and in the dedicated services. It is excluded, for instance, the replacement of a dirty or consumed footbed or the adjustment to the insole needed due to the variation of the physical characteristics of the foot due to traumas, lesions, accidents and so on.

Are also excluded interventions required by the improper use of the insole like using a footwear that was not previously approved by a TONUS orthopedic technician or skipping the Scheduled Routine Maintenance.

We are sure that we will be able to assist with all of your requests and needs thanks to our professionalism, and that you will always find the replies to all your questions in our company.