Active devices for therapy are intended to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap.
These devices may be intended to:
- administer energy to a patient or exchange energy to or from a patient
- administer or exchange energy to or with a patient in a potentially hazardous way considering the nature, density and site of application of the energy
- control or monitor, or directly influence, the performance of a device that delivers or exchanges energy to or with a patient in a potentially hazardous way.
Some examples of active devices for therapy (non-hazardous energy delivery) include devices for therapeutic massage, muscle stimulators, powered dental hand pieces, hearing aids, neonatal phototherapy equipment and ultrasound equipment for physiotherapy.
Some examples of active devices for therapy (potentially hazardous energy delivery) include electrocautery devices, UV or laser light devices for corneal modification, baby incubators, external pacemakers and defibrillators, lithotriptors, therapeutic X-ray and other sources of ionizing radiation.