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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, non-implantable, for incontinence
Regulation Description Nonimplanted electrical continence device.
Product CodeKPI
Regulation Number 876.5320
Device Class 2


Premarket Reviews
ManufacturerDecision
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EASYMED INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
FOTONA D.O.O.
  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 2
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TENSCARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
THOUGHT TECHNOLOGY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VERITY MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZMI ELECTRONICS , LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 5 5
Output Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Discomfort 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Dysuria 4 4
Muscle Weakness 4 4
Micturition Urgency 4 4
Superficial (First Degree) Burn 1 1
Abdominal Pain 1 1
Sleep Dysfunction 1 1
Electric Shock 1 1
Brain Injury 1 1
Fatigue 1 1
Nausea 1 1
Urinary Incontinence 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Memory Loss/Impairment 1 1
Confusion/ Disorientation 1 1
Burning Sensation 1 1
Diarrhea 1 1
Vertigo 1 1
Pain 1 1
Gastrointestinal Regurgitation 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 1
Undesired Nerve Stimulation 1 1
Unspecified Tissue Injury 1 1
Headache 1 1
Bruise/Contusion 1 1
Ambulation Difficulties 1 1

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