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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 2
AKTIIA SA
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 1
BEIJING HANVON HEALTH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOBEAT TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOZEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIO RING TECHNOLOGIES, INC. TAIWAN BRANCH
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CEMHO MEDICAL TECHNOLOGY (GUANGDONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CNSYSTEMS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN E-TEST TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 3
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HETAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HONSUN (NANTONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INBODY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOYTECH HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 8
KOROT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVEMETRIC (MEDICAL) S.A.
  SUBSTANTIALLY EQUIVALENT 1
LOTUSNINE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDITECH , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 5
MURATA VIOS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOWEAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO RANOR MEDICAL 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
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN GOODLYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HANHAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HBCARE TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN JAMR MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JAMR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT 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 3
SHENZHEN YOLANDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
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
2021 162 162
2022 155 158
2023 162 164
2024 270 270
2025 245 245
2026 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 274 274
Incorrect, Inadequate or Imprecise Result or Readings 256 259
High Readings 110 110
Incorrect Measurement 75 75
Failure to Deflate 42 42
Insufficient Information 42 42
No Audible Prompt/Feedback 39 39
Fracture 26 26
Output Problem 25 25
Low Readings 24 25
Inadequacy of Device Shape and/or Size 21 21
Inflation Problem 19 19
Smoking 19 19
No Audible Alarm 18 18
Overheating of Device 15 15
Material Separation 15 15
Patient-Device Incompatibility 15 15
Patient Device Interaction Problem 12 12
Fire 11 11
No Apparent Adverse Event 11 11
Pressure Problem 10 10
High Test Results 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Deflation Problem 10 10
Temperature Problem 8 8
Product Quality Problem 8 8
Battery Problem 8 8
Unable to Obtain Readings 8 8
Sparking 7 7
Defective Component 7 7
Defective Device 7 7
Loose or Intermittent Connection 6 6
Break 6 6
Detachment of Device or Device Component 6 6
Material Integrity Problem 6 6
Melted 5 5
Infusion or Flow Problem 5 5
Flare or Flash 5 5
Leak/Splash 5 5
Therapeutic or Diagnostic Output Failure 5 5
Image Display Error/Artifact 5 5
Failure to Power Up 4 4
Improper or Incorrect Procedure or Method 4 4
Display or Visual Feedback Problem 4 4
Material Deformation 4 5
Increase in Pressure 4 4
Imprecision 3 3
No Device Output 3 3
Device Displays Incorrect Message 3 3
Gas/Air Leak 3 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 789 791
Insufficient Information 107 109
Ecchymosis 88 88
Hemorrhage/Bleeding 22 22
High Blood Pressure/ Hypertension 19 20
Low Blood Pressure/ Hypotension 18 18
Pain 18 18
Bruise/Contusion 12 12
Numbness 11 11
Syncope/Fainting 5 5
Dizziness 5 5
Unspecified Tissue Injury 5 5
Fall 5 5
Loss of consciousness 4 4
Headache 4 4
Hypersensitivity/Allergic reaction 3 3
Hematoma 3 3
Physical Asymmetry 3 3
Easy Bruising 3 3
Swelling/ Edema 3 3
Loss of Range of Motion 3 3
Hyperglycemia 3 3
Discomfort 3 3
Unspecified Heart Problem 2 2
Cardiovascular Insufficiency 2 2
Blurred Vision 2 2
Abscess 2 2
Unspecified Kidney or Urinary Problem 2 2
Renal Impairment 2 2
Scar Tissue 2 2
Dyspnea 2 2
Concussion 2 2
Cellulitis 2 2
Cardiac Arrest 2 2
Myalgia 2 2
Abrasion 2 2
Stroke/CVA 2 2
Arrhythmia 2 2
Unspecified Eye / Vision Problem 1 1
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Thrombosis/Thrombus 1 1
Burning Sensation 1 1
Rash 1 1
Burn(s) 1 1
Bradycardia 1 1
Eye Injury 1 1
Reaction to Medicinal Component of Device 1 1
Tachycardia 1 1
Anxiety 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 PYRAMES INC II Apr-02-2025
6 Welch Allyn Inc II May-21-2021
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