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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, paraffin
Product CodeIMC
Regulation Number 890.5110
Device Class 2


Premarket Reviews
ManufacturerDecision
SHENZHEN COMFORT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2017 1 1
2018 3 3
2019 2 2
2020 1 1
2021 1 1
2022 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Overheating of Device 5 5
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Device Emits Odor 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 3 3
Burn(s) 2 2
Burning Sensation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Tingling 1 1
No Consequences Or Impact To Patient 1 1
Erythema 1 1
Pain 1 1
Swelling 1 1
Electric Shock 1 1
Superficial (First Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
No Information 1 1
Insufficient Information 1 1

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