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TPLC
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Device
electromyograph, diagnostic
Product Code
IKN
Regulation Number
890.1375
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K172743
Natus VikingQuest
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
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
Insufficient Information
3
3
Appropriate Term/Code Not Available
2
2
Device Sensing Problem
2
2
False Negative Result
2
2
Energy Output Problem
2
2
Overheating of Device
1
1
Unable to Obtain Readings
1
1
Sensing Intermittently
1
1
False Positive Result
1
1
Loose or Intermittent Connection
1
1
Signal Artifact/Noise
1
1
Display or Visual Feedback Problem
1
1
Compatibility Problem
1
1
Invalid Sensing
1
1
Patient-Device Incompatibility
1
1
Device Inoperable
1
1
Unintended Electrical Shock
1
1
Intermittent Energy Output
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
No Consequences Or Impact To Patient
10
10
Injury
10
10
Burn, Thermal
8
8
Misdiagnosis
5
5
Burn(s)
4
4
Pain
2
2
Insufficient Information
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Rash
1
1
Scar Tissue
1
1
Bruise/Contusion
1
1
Facial Nerve Paralysis
1
1
Nerve Damage
1
1
Undesired Nerve Stimulation
1
1
No Patient Involvement
1
1
Patient Problem/Medical Problem
1
1
Skin Tears
1
1
Partial thickness (Second Degree) Burn
1
1
Full thickness (Third Degree) Burn
1
1
Localized Skin Lesion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
SpineMatrix Inc
II
Jun-30-2010
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