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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, body composition
Regulation Description Impedance plethysmograph.
Product CodeMNW
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
ZHONGSHAN JINLI ELECTRONIC WEIGHING EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 12 12
2021 10 10
2022 8 8
2023 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 20 20
Appropriate Term/Code Not Available 5 5
Fire 2 2
Sparking 1 1
Burst Container or Vessel 1 1
Device Damaged Prior to Use 1 1
Fail-Safe Did Not Operate 1 1
Material Fragmentation 1 1
Fail-Safe Problem 1 1
Thermal Decomposition of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Explosion 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 3 3
Laceration(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Burn, Thermal 1 1
Burn(s) 1 1
No Consequences Or Impact To Patient 1 1

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