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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, measurement, blood-pressure, non-invasive
Product CodeDXN
Regulation Number 870.1130
Device Class 2


Premarket Reviews
ManufacturerDecision
A&D COMPANY, LTD
  SUBSTANTIALLY EQUIVALENT 2
A&D COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDITECH INC.
  SUBSTANTIALLY EQUIVALENT 1
AGELESS HEALTH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL (SHENZHEN), INC
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN, INC
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN,INC
  SUBSTANTIALLY EQUIVALENT 3
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
ATCOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARETAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CNSYSTEMS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
CONMO ELECTRONIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN E-TEST TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 4
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
FINAPRES MEDICAL SYSTEMS B.V.
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GMC INC.
  SUBSTANTIALLY EQUIVALENT 2
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HEALTH & LIFE CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTHSTATS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
HONSUN(NANTONG)CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
INBODY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
INBODY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT& SUPPLY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
JOYTECH HEALTHCARE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
LD TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVEMETRIC (MEDICAL) S.A.
  SUBSTANTIALLY EQUIVALENT 1
LOTUSNINE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDITECH LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CARE MANAGEMENT SERVICES
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 11
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 6
QARDIO INC
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO YASEE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RGB MEDICAL DEVICES SA
  SUBSTANTIALLY EQUIVALENT 1
RUDOLF RIESTER GMBH
  SUBSTANTIALLY EQUIVALENT 1
SECA GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMBEI TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN JAMR TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIACOM TECHNOLOGY CO ., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIACOM TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VISIOMED GROUP SA
  SUBSTANTIALLY EQUIVALENT 1
VITA-COURSE TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEONY (SHENZHEN) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
YA HORNG ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 617 617
2019 96 96
2020 130 130
2021 162 162
2022 155 155
2023 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 391 391
Incorrect, Inadequate or Imprecise Result or Readings 332 332
Device Displays Incorrect Message 239 239
Output Problem 224 224
Fluid/Blood Leak 211 211
Device Operates Differently Than Expected 200 200
Incorrect Or Inadequate Test Results 170 170
High Test Results 121 121
Incorrect Measurement 59 59
High Readings 45 45
Low Readings 45 45
No Audible Prompt/Feedback 35 35
No Audible Alarm 26 26
No Device Output 25 25
Defective Device 25 25
Overheating of Device 20 20
Therapeutic or Diagnostic Output Failure 18 18
Failure to Pump 17 17
Smoking 16 16
Inflation Problem 15 15
Application Program Freezes, Becomes Nonfunctional 14 14
Fire 12 12
Fracture 10 10
Break 10 10
Insufficient Information 10 10
Appropriate Term/Code Not Available 9 9
Display or Visual Feedback Problem 9 9
Inaudible or Unclear Audible Prompt/Feedback 9 9
Defective Component 8 8
No Display/Image 8 8
Failure to Power Up 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Detachment of Device or Device Component 8 8
Protective Measures Problem 7 7
Failure to Deflate 7 7
Loose or Intermittent Connection 7 7
Mechanical Problem 7 7
Leak/Splash 6 6
Electrical /Electronic Property Problem 6 6
Patient Device Interaction Problem 6 6
Computer Operating System Problem 6 6
Flare or Flash 6 6
Physical Property Issue 5 5
Device Fell 5 5
Product Quality Problem 5 5
Unable to Obtain Readings 5 5
Battery Problem 5 5
Malposition of Device 4 4
Low Test Results 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Alarm System 4 4
Improper Alarm 4 4
Failure to Shut Off 4 4
Pumping Problem 4 4
Pressure Problem 4 4
Inadequate User Interface 4 4
Infusion or Flow Problem 4 4
Electrical Shorting 3 3
No Apparent Adverse Event 3 3
Power Problem 3 3
Deflation Problem 3 3
Decrease in Pressure 3 3
Sparking 3 3
Device Issue 2 2
Device Inoperable 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Increase in Pressure 2 2
Crack 2 2
Material Discolored 2 2
Display Difficult to Read 2 2
Material Integrity Problem 2 2
Improper Device Output 2 2
Operating System Becomes Nonfunctional 2 2
Gas/Air Leak 2 2
Issue With Displayed Error Message 2 2
Electrical Power Problem 2 2
Device Sensing Problem 2 2
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Material Deformation 1 1
Failure to Auto Stop 1 1
Scratched Material 1 1
Temperature Problem 1 1
No Pressure 1 1
Intermittent Loss of Power 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Data Problem 1 1
Patient Data Problem 1 1
Air/Gas in Device 1 1
Erratic or Intermittent Display 1 1
Flushing Problem 1 1
Unintended Power Up 1 1
Defective Alarm 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Computer Software Problem 1 1
Failure to Run on Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 678 678
No Clinical Signs, Symptoms or Conditions 348 348
Insufficient Information 67 67
No Consequences Or Impact To Patient 65 65
No Patient Involvement 57 57
Ecchymosis 14 14
Pain 11 11
High Blood Pressure/ Hypertension 7 7
Dizziness 7 7
Low Blood Pressure/ Hypotension 6 6
Fall 6 6
Cardiac Arrest 5 5
Numbness 5 5
No Information 5 5
No Code Available 4 4
Syncope/Fainting 4 4
Loss of consciousness 4 4
Patient Problem/Medical Problem 3 3
Physical Asymmetry 3 3
Swelling/ Edema 3 3
Stroke/CVA 3 3
Hematoma 3 3
Hemorrhage/Bleeding 3 3
Bruise/Contusion 3 3
Loss of Range of Motion 3 3
Injury 3 3
Myalgia 2 2
Electrolyte Imbalance 2 2
Blurred Vision 2 2
Concussion 2 2
Pneumothorax 2 2
Laceration(s) 2 2
Nerve Damage 2 2
Hypersensitivity/Allergic reaction 2 2
Bone Fracture(s) 2 2
Headache 2 2
Fainting 2 2
Death 2 2
Cellulitis 2 2
Abrasion 2 2
Abscess 2 2
Arrhythmia 2 2
Missing Value Reason 2 2
Unspecified Heart Problem 2 2
Renal Impairment 2 2
Unspecified Kidney or Urinary Problem 2 2
Easy Bruising 1 1
Reaction to Medicinal Component of Device 1 1
Test Result 1 1
Tooth Fracture 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Bradycardia 1 1
Dyspnea 1 1
Hyperglycemia 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC I May-21-2019
2 Mediana Co., Ltd. II Jul-19-2021
3 Mediana Co., Ltd. II Jun-26-2020
4 Suntech Medical, Inc. II Jun-25-2020
5 Suntech Medical, Inc. II Jan-14-2020
6 Welch Allyn Inc II May-21-2021
7 Withings Sas II Aug-16-2018
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