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TPLC
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Device
stimulator, electrical, non-implantable, for incontinence
Product Code
KPI
Regulation Number
876.5320
Device Class
2
Premarket Reviews
Manufacturer
Decision
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FOTONA D.O.O.
SUBSTANTIALLY EQUIVALENT
1
INCONTROL MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT - KIT
1
INMODE LTD.
SUBSTANTIALLY EQUIVALENT
1
NANJING VISHEE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ORIENTAL INSPIRATION LIMITED
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN KONMED TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN KONMED TECHNOLOGY CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MED-LINK ELECTRONICS TECH CO, LTD
SUBSTANTIALLY EQUIVALENT
1
TENSCARE LTD
SUBSTANTIALLY EQUIVALENT
1
TENSCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
THOUGHT TECHNOLOGY LTD.
SUBSTANTIALLY EQUIVALENT
1
WELL-LIFE HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
ZIMMER MEDIZINSYSTEME GMBH
SUBSTANTIALLY EQUIVALENT
1
ZMI ELECTRONICS LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
3
3
2021
1
1
2022
2
2
2023
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Output Problem
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Dysuria
4
4
Muscle Weakness
4
4
Micturition Urgency
4
4
Discomfort
4
4
Pain
4
4
Headache
2
2
Abdominal Pain
1
1
Sleep Dysfunction
1
1
Superficial (First Degree) Burn
1
1
Electric Shock
1
1
Fatigue
1
1
Nausea
1
1
Sepsis
1
1
Brain Injury
1
1
Urinary Incontinence
1
1
Memory Loss/Impairment
1
1
Hematuria
1
1
Confusion/ Disorientation
1
1
Weakness
1
1
Burning Sensation
1
1
Injury
1
1
Diarrhea
1
1
Muscle Spasm(s)
1
1
Vomiting
1
1
Gastrointestinal Regurgitation
1
1
Muscle/Tendon Damage
1
1
Undesired Nerve Stimulation
1
1
Stenosis
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Inadequate Pain Relief
1
1
Cancer
1
1
Arthritis
1
1
Bruise/Contusion
1
1
Ambulation Difficulties
1
1
Lethargy
1
1
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