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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
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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