Decision tree
Heading
Active devices
Body
Additional categories of active devices include:
- Active devices for therapy: Active devices that are intended to be used to treat patients , by supporting, modifying replacing, or restoring biological functions or structures, while treating or alleviating an illness, injury or handicap. This includes Software that is used to provide therapy to a patient and instant chemical hot/cold packs indicated to help reduce pain and swelling etc.
- Active devices for diagnosis: Active devices that are intended to supply information for the purpose of detecting, diagnosing, monitoring, or treating physiological conditions, states of health, illnesses or congenital deformities. This includes Software that is used to aid in diagnosing a patient's condition
- Active devices for delivering or removing medicines or other substances to or from a patient's body
- Active devices for therapy with a diagnostic function where the purpose is to significantly determine patient management
- Other active devices: Any other active medical devices that are not covered by the categories above.
Question
Based on the above, which category applies to your active medical device?