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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
Product CodeMNW
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
AKERN USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOSPACE CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 5
BODYSTAT LTD.
  SUBSTANTIALLY EQUIVALENT 2
CONMO ELECTRONIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FITBIT, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOOK TIN TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
IPGDX, LLC
  SUBSTANTIALLY EQUIVALENT 1
JAWON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
L.D. TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION ONE LIFECARE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SECA GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD
  SUBSTANTIALLY EQUIVALENT 3
SHINE OVERSEAS MARKETING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STAYHEALTHY, INC.
  SUBSTANTIALLY EQUIVALENT 1
TANITA CORP.
  SUBSTANTIALLY EQUIVALENT 1
TANITA CORPORATION OF AMERICA
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN HUIBAO WEIGHING APPARATUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN JINLI ELECTRONIC WEIGHING EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 2 2
2016 15 15
2017 6 6
2018 16 16
2019 11 11
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 41 41
Material Fragmentation 6 6
Burst Container or Vessel 5 5
Appropriate Term/Code Not Available 5 5
Explosion 3 3
Insufficient Information 3 3
Expulsion 2 2
Scratched Material 2 2
Fire 2 2
Mechanical Problem 2 2
Device Damaged Prior to Use 2 2
Patient-Device Incompatibility 2 2
Material Disintegration 2 2
Self-Activation or Keying 2 2
Fail-Safe Problem 1 1
Extrusion 1 1
Sparking 1 1
Device Slipped 1 1
Mechanics Altered 1 1
Thermal Decomposition of Device 1 1
Detachment of Device or Device Component 1 1
Device Emits Odor 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Tipped Over 1 1
Physical Property Issue 1 1
Crack 1 1
Fail-Safe Did Not Operate 1 1
Device Operates Differently Than Expected 1 1
Melted 1 1
Overheating of Device 1 1
Improper or Incorrect Procedure or Method 1 1
False Positive Result 1 1
Electrical /Electronic Property Problem 1 1
Premature Discharge of Battery 1 1
Unintended Collision 1 1
Component Falling 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 13 13
Injury 8 8
Laceration(s) 5 5
Insufficient Information 4 4
No Information 3 3
Pain 2 2
Sleep Dysfunction 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Misdiagnosis 1 1
Dizziness 1 1
Test Result 1 1
Inflammation 1 1
Burn, Thermal 1 1
Burn(s) 1 1
No Patient Involvement 1 1
Discomfort 1 1
Partial thickness (Second Degree) Burn 1 1
Tissue Damage 1 1
Atrial Flutter 1 1
Device Embedded In Tissue or Plaque 1 1

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