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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
ALICN MEDICAL (SHENZHEN), 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 5
ATCOR MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AVICHE SHANDONG MEDICAL TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  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 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
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 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
HEALTH & LIFE CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HETAIDA TECHNOLOGY 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
JIANGXI AICARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
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 9
NANOWEAR INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO RANOR MEDICAL SCIENCE & 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 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 FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN GOODLYMED TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HINGMED MEDICAL INSTRUMENT 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 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 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 3
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
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 96
2020 130 130
2021 162 162
2022 155 155
2023 165 165
2024 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 230 230
Incorrect, Inadequate or Imprecise Result or Readings 148 148
Incorrect Measurement 71 71
High Readings 49 49
No Audible Prompt/Feedback 39 39
Insufficient Information 22 22
No Audible Alarm 20 20
Smoking 19 19
Overheating of Device 18 18
Therapeutic or Diagnostic Output Failure 18 18
Defective Device 15 15
Low Readings 14 14
Failure to Deflate 14 14
Output Problem 13 13
Device Displays Incorrect Message 13 13
Application Program Freezes, Becomes Nonfunctional 11 11
Fire 10 10
Break 10 10
Fracture 10 10
Inflation Problem 9 9
High Test Results 9 9
Detachment of Device or Device Component 9 9
Inaudible or Unclear Audible Prompt/Feedback 8 8
Defective Component 8 8
Sparking 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Power Up 7 7
Inadequacy of Device Shape and/or Size 7 7
Loose or Intermittent Connection 6 6
Flare or Flash 6 6
Display or Visual Feedback Problem 6 6
Computer Operating System Problem 6 6
Deflation Problem 6 6
Patient Device Interaction Problem 6 6
Appropriate Term/Code Not Available 5 5
Melted 5 5
Patient-Device Incompatibility 5 5
Device Fell 5 5
Product Quality Problem 5 5
Unable to Obtain Readings 5 5
Protective Measures Problem 4 4
Device Alarm System 4 4
No Display/Image 4 4
Pressure Problem 4 4
Inadequate User Interface 4 4
Battery Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Shut Off 3 3
Electrical Shorting 3 3
No Apparent Adverse Event 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 470 470
No Known Impact Or Consequence To Patient 106 106
Insufficient Information 82 82
No Consequences Or Impact To Patient 46 46
No Patient Involvement 36 36
Ecchymosis 36 36
Pain 13 13
Low Blood Pressure/ Hypotension 12 12
High Blood Pressure/ Hypertension 8 8
Bruise/Contusion 8 8
Dizziness 7 7
Hemorrhage/Bleeding 7 7
Numbness 6 6
Fall 6 6
Syncope/Fainting 4 4
Cardiac Arrest 4 4
Stroke/CVA 3 3
Bone Fracture(s) 3 3
Hematoma 3 3
Headache 3 3
Physical Asymmetry 3 3
Swelling/ Edema 3 3
Loss of Range of Motion 3 3
Loss of consciousness 2 2
Fainting 2 2
Unspecified Heart Problem 2 2
Blurred Vision 2 2
Abscess 2 2
Unspecified Kidney or Urinary Problem 2 2
Renal Impairment 2 2
Laceration(s) 2 2
Concussion 2 2
Nerve Damage 2 2
Electrolyte Imbalance 2 2
Cellulitis 2 2
Easy Bruising 2 2
Myalgia 2 2
Abrasion 2 2
Pneumothorax 2 2
Hypersensitivity/Allergic reaction 2 2
Arrhythmia 2 2
Dyspnea 1 1
Hyperglycemia 1 1
Scar Tissue 1 1
Rash 1 1
Skin Discoloration 1 1
Bradycardia 1 1
Reaction 1 1
Vascular System (Circulation), Impaired 1 1
Reaction to Medicinal Component of Device 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 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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