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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 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 2 2

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
Scratched Material 2 2
Device Damaged Prior to Use 2 2
Patient-Device Incompatibility 2 2
Expulsion 2 2
Material Disintegration 2 2
Fire 2 2
Self-Activation or Keying 2 2
Mechanical Problem 2 2
Melted 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Labelling, Instructions for Use or Training Problem 1 1
Premature Discharge of Battery 1 1
Electrical /Electronic Property Problem 1 1
False Positive Result 1 1
Component Falling 1 1
Crack 1 1
Thermal Decomposition of Device 1 1
Extrusion 1 1
Fail-Safe Problem 1 1
Mechanics Altered 1 1
Physical Property Issue 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Tipped Over 1 1
Sparking 1 1
Temperature Problem 1 1
Fail-Safe Did Not Operate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
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
Tissue Damage 1 1
Misdiagnosis 1 1
Dizziness 1 1
Discomfort 1 1
Atrial Flutter 1 1
Burn(s) 1 1
Inflammation 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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