Stimulator, Low Electric Field, Tumor Treatment
The Stimulator, Low Electric Field, Tumor Treatment (product code NZK) is a device that applies low-intensity, alternating electric fields (tumor treating fields) to treat solid tumors, indicated specifically for the treatment of recurrent glioblastoma multiforme (GBM) in patients who have received maximum standard therapy with continued disease progression defined by tumor growth or neurological decline. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Neurology panel. This device carries a life-sustaining flag, reflecting its use in treating a life-threatening condition.
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Basic Information
- Product Code
- NZK
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.