2007/47 on medical devices, by the Notified Body Kiwa Cermet Italia, Via Cadriano 23,
40057 Granarolo Dell’Emilia (BO) Italy (n. 0476), in order to ensure product safety.
INTENDED USE
The after sales service is guaranteed for 5 years. We suggest having a check of the
device every 2 years for the maintenance and to ensure the safety. The numbers of
treatments depend on the battery charge.
The risk class of the device is IIb.
The intended use of the device is to provide:
- analgesic electrotherapy through stimulation of the peripheral nervous system;
- muscle electrostimulation in order to reduce atrophy and spasticity and increase
muscle strength.
The electrostimulators are designed to be used in the following operating environments:
- domestic environment;
- clinics;
- physiotherapy centers;
- rehabilitation centers;
- general pain treatments;
- beauty and sport purposes (CE0476 does not refer to non-medical treatments);
The use of this device is permitted to the patient (appropriately informed about the use
conditions of the device) and to medical staff.
The user of these devices must be able to
understand and want and be at least 18 years old.
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