Product code NZK

Device name

Stimulator, Low Electric Field, Tumor Treatment

Medical specialty

Unknown

Device class

3

Review panel

NE

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset