Stimulator, Low Electric Field, Tumor Treatment

NZK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: NZK
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: NE
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 8

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown