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
| Device Type ID | 3854 |
| Device Name | Stimulator, Low Electric Field, Tumor Treatment |
| Physical State | The Device Consists Of Sets Of Contact Electrodes That Are Applied To The Patient's Shaved Head, A Connecting Cable And A Belt Mounted Control Box And Signal Generator. The Sets Are 3 Electrodes Each Adn There Can Be 2 Or 3 Sets Used At A Time. |
| Technical Method | This Is A Battery Powered Device. Electric Fields That Alter Thier Polarity At A Frequency Near 200kHz With An Intensity Near 0.7 V/cm Are Continuosly Applied To The Target Tumor 24 Hours A Day For 6 Months At A Time. This Electric Field Creates, Dur |
| Target Area | The Device Is Currently Used Only On The Human Head. |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NZK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3854 |
| Device | Stimulator, Low Electric Field, Tumor Treatment |
| Product Code | NZK |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 77 |
| Total Device Problems | 77 |