NZK
- Product code
- NZK
- Device name
- Stimulator, Low Electric Field, Tumor Treatment
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
- Flag
- Life-sustaining / life-supporting
FDA classification definition
Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Official FDA classification page: NZK
Classification and pathway per current FDA publications. Data from openFDA (CC0).