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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
80 BEATS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
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
GUANGZHOU DAXIN HEALTH TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAPPY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HETAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HONSUN (NANTONG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 9
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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 5
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 4
SHENZHEN YOLANDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YUEZHONGXING TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN ZHONGKEMINGWANG TELECOMMUNICATIONS SOFTWARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZIQING MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAIWAN SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOURNICARE PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELLVII, INC.
  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 1102 1103

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 387 388
Fluid/Blood Leak 282 282
High Readings 198 199
Unable to Obtain Readings 133 133
Inflation Problem 131 131
Incorrect Measurement 128 129
Failure to Power Up 111 111
Image Display Error/Artifact 83 83
Device Provides Uninformative Message 63 63
Insufficient Device Problem Information 49 49
Failure to Deflate 43 43
Output Problem 40 40
No Audible Prompt/Feedback 38 38
Low Readings 33 33
Display or Visual Feedback Problem 33 33
Electrical /Electronic Property Problem 30 30
Fracture 28 28
Inadequacy of Device Shape and/or Size 21 21
Calibration Problem 20 20
Imprecision 20 20
Computer Software Problem 20 20
Smoking 19 19
No Audible Alarm 17 17
High Test Results 17 17
Overheating of Device 16 16
Patient-Device Incompatibility 15 15
Material Separation 15 15
Imprecise or Erratic Results 14 14
Gas/Air Leak 13 13
Pressure Problem 12 12
Temperature Problem 12 12
No Apparent Adverse Event 11 11
Patient Device Interaction Problem 11 11
Fire 11 11
Leak/Splash 11 11
Deflation Problem 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Battery Problem 9 9
Power Problem 8 8
Loose or Intermittent Connection 8 8
Mechanical Problem 8 8
Sparking 7 7
Display Difficult to Read 6 6
Detachment of Device or Device Component 6 6
Infusion or Flow Problem 6 6
Human-Device Interface Problem 5 5
Pumping Problem 5 5
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Device Displays Incorrect Message 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1756 1759
Insufficient Information 115 117
Ecchymosis 89 89
Hemorrhage/Blood Loss/Bleeding 22 22
High Blood Pressure/ Hypertension 19 20
Pain 19 19
Low Blood Pressure/ Hypotension 18 18
Bruise/Contusion 12 12
Numbness 11 11
Syncope/Fainting 5 5
Unspecified Tissue Injury 5 5
Dizziness 5 5
Fall 5 5
Loss of Range of Motion 5 5
Loss of consciousness 4 4
Headache 4 4
Stroke/CVA 4 4
Discomfort 4 4
Physical Asymmetry 3 3
Swelling/ Edema 3 3
Limb Pain 3 3
Hyperglycemia 3 3
Hypersensitivity/Allergic reaction 3 3
Easy Bruising 3 3
Hematoma 3 3
Muscle Weakness/Atrophy 2 2
Intracranial Pressure Increased 2 2
Arrhythmia 2 2
Unspecified Heart Problem 2 2
Blurred Vision 2 2
Cardiovascular Dysfunction/Insufficiency 2 2
Muscle/Tendon Damage 2 2
Abscess 2 2
Unspecified Kidney or Urinary Problem 2 2
Renal Impairment 2 2
Visual Impairment 2 2
Scar Tissue 2 2
Abrasion 2 2
Myalgia 2 2
Dyspnea 2 2
Concussion 2 2
Cardiac Arrest 2 2
Tooth Loss 2 2
Cellulitis 2 2
Bone Fracture(s) 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Eye / Vision Problem 1 1
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Blister 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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