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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
Product CodeKPI
Regulation Number 876.5320
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCELERATED CARE PLUS
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EVERYWAY MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FUJI DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
INCONTROL MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 5
INCONTROL MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL TRADE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
NANJING VISHEE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORIENTAL INSPIRATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KONMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 3
THOUGHT TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERITY SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL-LIFE HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER MEDIZINSYSTEME GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZMI ELECTRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZYNEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2017 4 4
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
Insufficient Information 2 2
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Electronic Property Issue 1 1
Break 1 1
Deflation Problem 1 1
Leak/Splash 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 5 5
Discomfort 5 5
Dysuria 4 4
Micturition Urgency 4 4
Muscle Weakness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Headache 2 2
Electric Shock 2 2
Hematuria 1 1
Lethargy 1 1
No Patient Involvement 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Superficial (First Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Cancer 1 1
Gastrointestinal Regurgitation 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Urinary Incontinence 1 1
Swelling/ Edema 1 1
Unspecified Infection 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Abdominal Pain 1 1
Arthritis 1 1
Bruise/Contusion 1 1
Diarrhea 1 1
Fatigue 1 1
Sepsis 1 1
Vomiting 1 1
Weakness 1 1
Burning Sensation 1 1
Cramp(s) 1 1
Brain Injury 1 1
Stenosis 1 1
Nausea 1 1
Undesired Nerve Stimulation 1 1

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