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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electromyograph, diagnostic
Product CodeIKN
Regulation Number 890.1375
Device Class 2


Premarket Reviews
ManufacturerDecision
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DORSA VI PTY. LTD
  SUBSTANTIALLY EQUIVALENT 1
DORSAVI LTD
  SUBSTANTIALLY EQUIVALENT 1
DORSAVI LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATUS NEUROLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
OKTX LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION BIOMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEMATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEEMG, LLC USA
  SUBSTANTIALLY EQUIVALENT 1
UROVAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 13 13
2016 11 11
2017 2 2
2018 5 5
2019 6 6
2020 1 1
2021 2 2
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 11 11
Device-Device Incompatibility 7 7
Defibrillation/Stimulation Problem 6 6
Device Operational Issue 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Use of Device Problem 4 4
False Negative Result 3 3
Insufficient Information 3 3
Energy Output Problem 2 2
Device Sensing Problem 2 2
Appropriate Term/Code Not Available 2 2
Signal Artifact/Noise 1 1
Compatibility Problem 1 1
Sensing Intermittently 1 1
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Patient-Device Incompatibility 1 1
Invalid Sensing 1 1
Unable to Obtain Readings 1 1
Overheating of Device 1 1
Device Inoperable 1 1
Display or Visual Feedback Problem 1 1
False Positive Result 1 1
Loose or Intermittent Connection 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
Injury 10 10
No Consequences Or Impact To Patient 10 10
Burn, Thermal 8 8
Misdiagnosis 5 5
Burn(s) 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Pain 2 2
Patient Problem/Medical Problem 1 1
Localized Skin Lesion 1 1
Rash 1 1
Nerve Damage 1 1
No Patient Involvement 1 1
Scar Tissue 1 1
Undesired Nerve Stimulation 1 1
Skin Tears 1 1
Partial thickness (Second Degree) Burn 1 1
Facial Nerve Paralysis 1 1
Full thickness (Third Degree) Burn 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 SpineMatrix Inc II Jun-30-2010
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