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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
Regulation Description Noninvasive blood pressure measurement system.
Product CodeDXN
Regulation Number 870.1130
Device Class 2


Premarket Reviews
ManufacturerDecision
A&D COMPANY, LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDITECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN, INC
  SUBSTANTIALLY EQUIVALENT 2
ALICN MEDICAL SHENZHEN,INC
  SUBSTANTIALLY EQUIVALENT 3
ANDON HEALTH CO LTD
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ATCOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BIOBEAT TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
CARETAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CNSYSTEMS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
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 2
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
HEALTH & LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HETAIDA TECHNOLOGY CO., LTD.
  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
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
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 7
MURATA VIOS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOWEAR INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PURSUANT HEALTH
  SUBSTANTIALLY EQUIVALENT 1
PYRAMES INC.
  SUBSTANTIALLY EQUIVALENT 1
QARDIO INC
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO YASEE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SECA GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN GOODLYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HBCARE TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN JAMR TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN RUIANKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN URION TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHONGKEMINGWANG TELECOMMUNICATIONS SOFTWARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU YOSUN MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WEONY (SHENZHEN) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 130 130
2021 162 162
2022 155 155
2023 165 165
2024 270 270
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 247 247
Incorrect, Inadequate or Imprecise Result or Readings 156 156
High Readings 75 75
Incorrect Measurement 65 65
No Audible Prompt/Feedback 39 39
Insufficient Information 36 36
Failure to Deflate 34 34
Inadequacy of Device Shape and/or Size 19 19
Overheating of Device 19 19
No Audible Alarm 19 19
Low Readings 15 15
Smoking 15 15
Inflation Problem 14 14
Output Problem 14 14
Patient-Device Incompatibility 14 14
Therapeutic or Diagnostic Output Failure 12 12
Patient Device Interaction Problem 11 11
Deflation Problem 10 10
Fracture 10 10
High Test Results 9 9
Fire 9 9
Detachment of Device or Device Component 9 9
Failure to Power Up 9 9
Application Program Freezes, Becomes Nonfunctional 8 8
Defective Component 8 8
Device Displays Incorrect Message 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Product Quality Problem 7 7
Break 7 7
Sparking 6 6
Loose or Intermittent Connection 6 6
Flare or Flash 6 6
Unable to Obtain Readings 6 6
Battery Problem 5 5
No Apparent Adverse Event 5 5
Improper or Incorrect Procedure or Method 4 4
Defective Device 4 4
Pressure Problem 4 4
Melted 4 4
Inaudible or Unclear Audible Prompt/Feedback 4 4
Appropriate Term/Code Not Available 3 3
Computer Operating System Problem 3 3
Display or Visual Feedback Problem 3 3
Display Difficult to Read 3 3
Temperature Problem 3 3
Infusion or Flow Problem 3 3
Inadequate User Interface 3 3
Electrical Shorting 3 3
No Display/Image 3 3
Protective Measures Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 544 544
Insufficient Information 91 91
Ecchymosis 77 77
No Known Impact Or Consequence To Patient 46 46
Hemorrhage/Bleeding 18 18
Pain 18 18
No Consequences Or Impact To Patient 18 18
No Patient Involvement 16 16
Low Blood Pressure/ Hypotension 14 14
Bruise/Contusion 13 13
High Blood Pressure/ Hypertension 11 11
Numbness 10 10
Fall 6 6
Dizziness 5 5
Syncope/Fainting 4 4
Physical Asymmetry 3 3
Hematoma 3 3
Headache 3 3
Hyperglycemia 3 3
Hypersensitivity/Allergic reaction 3 3
Swelling/ Edema 3 3
Easy Bruising 3 3
Bone Fracture(s) 3 3
Loss of Range of Motion 3 3
Concussion 2 2
Arrhythmia 2 2
Cardiac Arrest 2 2
Renal Impairment 2 2
Abscess 2 2
Stroke/CVA 2 2
Scar Tissue 2 2
Dyspnea 2 2
Fainting 2 2
Blurred Vision 2 2
Laceration(s) 2 2
Loss of consciousness 2 2
Nerve Damage 2 2
Cellulitis 2 2
Unspecified Kidney or Urinary Problem 2 2
Abrasion 2 2
Electrolyte Imbalance 2 2
Myalgia 2 2
Unspecified Heart Problem 2 2
Hearing Impairment 1 1
Cardiovascular Insufficiency 1 1
Reaction 1 1
Reaction to Medicinal Component of Device 1 1
Rash 1 1
Skin Inflammation/ Irritation 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-10-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Oct-08-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-01-2024
4 Mediana Co., Ltd. II Jul-19-2021
5 Mediana Co., Ltd. II Jun-26-2020
6 Suntech Medical, Inc. II Jun-25-2020
7 Suntech Medical, Inc. II Jan-14-2020
8 Welch Allyn Inc II May-21-2021
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