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TPLC
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show TPLC since
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Device
interferential current therapy
Product Code
LIH
Regulation Number
882.5890
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALAN NEUROMEDICAL TECHNOLOGIES LLC
SUBSTANTIALLY EQUIVALENT
1
ARTAFLEX INC.
SUBSTANTIALLY EQUIVALENT
1
BIO PROTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FUJI DYNAMICS LIMITED
SUBSTANTIALLY EQUIVALENT
1
GEMORE TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
THERASIGMA, LLC
SUBSTANTIALLY EQUIVALENT
1
VISION QUEST INDUSTRIES INC./ DBA VQ ORTHOCARE
SUBSTANTIALLY EQUIVALENT
1
WELL-LIFE HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2017
1
1
2019
1
1
2021
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2
2
Unintended Power Up
1
1
Insufficient Information
1
1
Unexpected Therapeutic Results
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Partial thickness (Second Degree) Burn
2
2
Unspecified Infection
1
1
High Blood Pressure/ Hypertension
1
1
Edema
1
1
Alteration In Body Temperature
1
1
Burn(s)
1
1
Erythema
1
1
Discomfort
1
1
Pain
1
1
Shock
1
1
Full thickness (Third Degree) Burn
1
1
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