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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 1
BOZHOU RONGJIAN MEDICAL APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
DELTA INTERNATIONAL SERVICES & LOGISTICS S.R.L
  SUBSTANTIALLY EQUIVALENT 1
FAST TRACK TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIMER MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GONGGUAN TUTAMEN METALWORK CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ORIENTAL INSPIRATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PIERENKEMPER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SUBLIMED
  SUBSTANTIALLY EQUIVALENT 1
TENSCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
TRUERELIEF
  SUBSTANTIALLY EQUIVALENT 1
WAT MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ZYNEX MEDICAL OFFICER
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 10 10
2021 5 5
2022 4 4
2023 39 39
2024 12 12
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 23 23
Adverse Event Without Identified Device or Use Problem 9 9
Break 4 4
Improper or Incorrect Procedure or Method 3 3
Thermal Decomposition of Device 3 3
Use of Device Problem 3 3
Patient-Device Incompatibility 2 2
Output Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Circuit Failure 1 1
Fire 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem 1 1
Positioning Problem 1 1
Electromagnetic Interference 1 1
Smoking 1 1
Energy Output Problem 1 1
Mechanical Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unintended Movement 1 1
Positioning Failure 1 1
Charging Problem 1 1
Failure to Power Up 1 1
Defective Component 1 1
Inadequate or Insufficient Training 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 15 15
Burn(s) 10 10
Pain 7 7
Erythema 7 7
Blister 6 6
Full thickness (Third Degree) Burn 5 5
Burn, Thermal 4 4
Discomfort 4 4
Electric Shock 3 3
Superficial (First Degree) Burn 3 3
No Consequences Or Impact To Patient 3 3
Partial thickness (Second Degree) Burn 3 3
Device Overstimulation of Tissue 2 2
Itching Sensation 2 2
Arrhythmia 2 2
Burning Sensation 2 2
Hypersensitivity/Allergic reaction 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Inadequate Pain Relief 2 2
Neuropathy 1 1
Fall 1 1
Undesired Nerve Stimulation 1 1
Tissue Damage 1 1
Failure of Implant 1 1
Hypoesthesia 1 1
Muscle Stimulation 1 1
Skin Inflammation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Skin Burning Sensation 1 1
Reaction 1 1
Shock from Patient Lead(s) 1 1
Numbness 1 1

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