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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve, transcutaneous, for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Product CodeGZJ
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOWAVE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FUJI DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
PIERENKEMPER GMBH
  SUBSTANTIALLY EQUIVALENT 1
RELIEFBAND TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
XANACARE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
XAVANT TECHNOLOGY (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 18 18
2016 32 32
2017 58 58
2018 21 21
2019 7 7
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 79 79
Device Operates Differently Than Expected 11 11
Temperature Problem 8 8
Power Cord 7 7
Insufficient Information 6 6
Charred 6 6
Improper or Incorrect Procedure or Method 5 5
Device Issue 4 4
Loss of Power 4 4
Break 3 3
Human Factors Issue 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Electrical /Electronic Property Problem 3 3
Output Problem 2 2
Patient-Device Incompatibility 2 2
Pad 2 2
Mechanical Problem 2 2
Overheating of Device 2 2
Use of Device Problem 2 2
Device Operational Issue 2 2
Failure to Shut Off 1 1
Defective Device 1 1
Sparking 1 1
Device Slipped 1 1
Melted 1 1
Nonstandard Device 1 1
Fire 1 1
Fracture 1 1
Electrode 1 1
PC (Printed Circuit) Board 1 1
Physical Property Issue 1 1
Material Protrusion/Extrusion 1 1
Appropriate Term/Code Not Available 1 1
Device Component Or Accessory 1 1
Loose or Intermittent Connection 1 1
Power Conditioning Problem 1 1
Product Quality Problem 1 1
Self-Activation or Keying 1 1
Interface 1 1
Circuit Failure 1 1
Battery 1 1
User Interface 1 1
Electrical Lead/Wire 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Fitting Problem 1 1
Low Test Results 1 1
Electronic Property Issue 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Electrode Contact 1 1
Patient Lead 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 43 43
Burn(s) 29 29
Full thickness (Third Degree) Burn 12 12
Pain 12 12
Burn, Thermal 11 11
Shock 6 6
No Consequences Or Impact To Patient 5 5
Lead(s), Burn(s) From 4 4
No Known Impact Or Consequence To Patient 4 4
Discomfort 4 4
No Information 4 4
Electric Shock 3 3
Shaking/Tremors 3 3
Tissue Damage 3 3
Burning Sensation 3 3
Headache 3 3
Unspecified Infection 3 3
Shock from Patient Lead(s) 3 3
Neck Pain 2 2
Rash 2 2
Nausea 2 2
Nerve Damage 2 2
Hemorrhage/Bleeding 2 2
Muscle Stimulation 2 2
Tingling 2 2
Scarring 2 2
Inflammation 2 2
Muscle Spasm(s) 1 1
Loss of Range of Motion 1 1
No Code Available 1 1
Fall 1 1
Vitreous Floaters 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Twitching 1 1
Dizziness 1 1
Therapeutic Response, Decreased 1 1
Vomiting 1 1
Paralysis 1 1
Scar Tissue 1 1
Atrial Fibrillation 1 1
Undesired Nerve Stimulation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Skin Irritation 1 1
Swelling 1 1
Ventricular Tachycardia 1 1
Convulsion, Tonic 1 1
Deformity/ Disfigurement 1 1
Numbness 1 1
Loss of consciousness 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Caustic/Chemical Burns 1 1
Abdominal Distention 1 1
Superficial (First Degree) Burn 1 1

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