• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device stimulator, low electric field, tumor treatment
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.
Product CodeNZK
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 4 1 1 7 1

MDR Year MDR Reports MDR Events
2020 30 30
2021 32 32
2022 26 26
2023 29 29
2024 156 156
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 291 291
Device-Device Incompatibility 1 1
Use of Device Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 82 82
Post Operative Wound Infection 59 59
Laceration(s) 46 46
Skin Inflammation/ Irritation 39 39
Ulcer 28 28
Fall 27 27
Convulsion/Seizure 12 12
Skin Infection 11 11
Headache 9 9
Post Traumatic Wound Infection 8 8
Limb Fracture 6 6
Cerebrospinal Fluid Leakage 6 6
Impaired Healing 6 6
Vertebral Fracture 5 5
Electric Shock 4 4
Hypersensitivity/Allergic reaction 4 4
Speech Disorder 3 3
Anxiety 3 3
Arthralgia 3 3
Cellulitis 3 3
Abscess 3 3
Bone Fracture(s) 2 2
Hematoma 2 2
Intracranial Hemorrhage 2 2
Multiple Fractures 2 2
Bruise/Contusion 2 2
Osteomyelitis 2 2
Abrasion 2 2
Distress 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Strangulation 2 2
Skin Erosion 2 2
Cognitive Changes 2 2
Sensitivity of Teeth 1 1
Depression 1 1
Hip Fracture 1 1
Choking 1 1
Radiodermatitis 1 1
Ambulation Difficulties 1 1
Myalgia 1 1
Dry Mouth 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Suicidal Ideation 1 1
Neuralgia 1 1
Balance Problems 1 1
Hydrocephalus 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Solid Tumour 1 1
Localized Skin Lesion 1 1

-
-