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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 3
ACCURATE MEDITECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
AKTIIA SA
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL (SHENZHEN), INC.
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN, INC.
  SUBSTANTIALLY EQUIVALENT 5
ANDON HEALTH CO, LTD.
  SUBSTANTIALLY EQUIVALENT 7
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
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 2
CONMO ELECTRONIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN E-TEST TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 5
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GMC, INC.
  SUBSTANTIALLY EQUIVALENT 2
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
HETAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HONSUN (NANTONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
I.E.M. INDUSTRIELLE ENTWICKLUNG AND MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
INBODY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
JIANGSU YUYUE MEDICAL EQUIPMENT& SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOYTECH HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 8
KOROT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 9
MURATA VIOS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOWEAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NINGBO RANOR MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 3
PURSUANT HEALTH
  SUBSTANTIALLY EQUIVALENT 1
PYRAMES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 7
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN GOODLYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HBCARE TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 5
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 2
SHENZHEN RUIANKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN URION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YOLANDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHONGKEMINGWANG TELECOMMUNICATIONS SOFTWARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
VITA-COURSE TECHNOLOGIES CO., LTD.
  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
XUZHOU YONGKANG ELECTRONIC SCIENCE 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
2019 96 98
2020 130 131
2021 162 162
2022 155 158
2023 162 164
2024 270 270
2025 245 245
2026 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 314 314
Incorrect, Inadequate or Imprecise Result or Readings 260 266
Incorrect Measurement 92 92
High Readings 88 88
No Audible Prompt/Feedback 45 45
Failure to Deflate 42 42
Insufficient Information 42 42
Fracture 27 27
No Audible Alarm 27 27
Output Problem 25 25
Low Readings 24 25
Overheating of Device 22 22
Smoking 22 22
Inadequacy of Device Shape and/or Size 21 21
Defective Device 20 20
Therapeutic or Diagnostic Output Failure 18 18
Patient-Device Incompatibility 16 16
Material Separation 15 15
Inflation Problem 15 15
Device Displays Incorrect Message 14 14
Fire 13 13
Application Program Freezes, Becomes Nonfunctional 13 13
Patient Device Interaction Problem 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Break 11 11
No Apparent Adverse Event 11 11
Deflation Problem 10 10
High Test Results 10 10
Sparking 9 9
Battery Problem 9 9
Failure to Power Up 9 9
Detachment of Device or Device Component 9 9
Product Quality Problem 9 9
Defective Component 9 9
Pressure Problem 8 8
Inaudible or Unclear Audible Prompt/Feedback 8 8
Unable to Obtain Readings 7 7
Material Integrity Problem 7 9
Computer Operating System Problem 6 6
Flare or Flash 6 6
Display or Visual Feedback Problem 6 6
Loose or Intermittent Connection 6 6
Temperature Problem 6 6
Protective Measures Problem 5 5
Infusion or Flow Problem 5 5
Appropriate Term/Code Not Available 5 5
Melted 5 5
Leak/Splash 5 5
Device Fell 5 5
Increase in Pressure 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 753 755
No Known Impact Or Consequence To Patient 106 109
Insufficient Information 105 107
Ecchymosis 88 88
No Consequences Or Impact To Patient 46 46
No Patient Involvement 36 36
Hemorrhage/Bleeding 22 22
Pain 20 20
Low Blood Pressure/ Hypotension 19 19
High Blood Pressure/ Hypertension 18 19
Bruise/Contusion 13 13
Numbness 11 11
Dizziness 8 8
Fall 6 6
Syncope/Fainting 5 5
Headache 4 4
Unspecified Tissue Injury 4 4
Cardiac Arrest 4 4
Stroke/CVA 3 3
Hypersensitivity/Allergic reaction 3 3
Loss of consciousness 3 3
Bone Fracture(s) 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
Fainting 2 2
Cardiovascular Insufficiency 2 2
Unspecified Heart Problem 2 2
Blurred Vision 2 2
Abscess 2 2
Dyspnea 2 2
Unspecified Kidney or Urinary Problem 2 2
Scar Tissue 2 2
Renal Impairment 2 2
Laceration(s) 2 2
Concussion 2 2
Nerve Damage 2 2
Cellulitis 2 2
Electrolyte Imbalance 2 2
Myalgia 2 2
Abrasion 2 2
Arrhythmia 2 2
Pneumothorax 2 2
Unspecified Eye / Vision Problem 1 1
Burning Sensation 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-10-2024
2 Edwards Lifesciences, LLC I May-21-2019
3 MEDLINE INDUSTRIES, LP - Northfield II Oct-08-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-01-2024
5 Mediana Co., Ltd. II Jul-19-2021
6 Mediana Co., Ltd. II Jun-26-2020
7 PYRAMES INC II Apr-02-2025
8 Suntech Medical, Inc. II Jun-25-2020
9 Suntech Medical, Inc. II Jan-14-2020
10 Welch Allyn Inc II May-21-2021
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