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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device thermometer, electronic, clinical
Product CodeFLL
Regulation Number 880.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
AION BIOSYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
ALICN MEDICAL SHENZHEN, INC
  SUBSTANTIALLY EQUIVALENT 3
ALICN MEDICAL SHENZHEN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALICN MEDICAL SHENZHEN,INC
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUE SPARK TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAP
  SUBSTANTIALLY EQUIVALENT 1
BROADMASTER BIOTECH, CORP.
  SUBSTANTIALLY EQUIVALENT 2
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIRCA SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CONMO ELECTRONIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN E-TEST TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN XINTAI INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FAMIDOC TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FIAB SPA
  SUBSTANTIALLY EQUIVALENT 1
GUANDONG GENIAL TECHNOLOGY CO., LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
HADLEIGH HEALTH TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU QINGYUAN MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEITAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HETAIDA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HONSUN (NANTONG) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN ZHONGXIN PACKING MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUBDIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN HONGGAO ELECTRONIC TECHNOLOFY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IWEECARE 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
JIAXING SHANGJIA INTELLIGENCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JOYTECH HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JOYTECH HEALTHCARE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KANGFU MEDICAL EQUIPMENT FACTORY
  SUBSTANTIALLY EQUIVALENT 1
KANGZHAN COMMUNICATION ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KAZ USA, INC., A HELEN OF TROY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
LIFE SCIENCE TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
LONGNAN RENZHONG MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
METKO MEDIKAL VE TTBBI CIHAZLAR D1S TICARET LTD. STI
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 3
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PHOENIX INNOVATIVE HEALTHCARE MANUFACTURERS PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
PUTIAN HANJIANG HUAFENG PLASTIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO YASEE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SENSATRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG BITTEL INTELLIGENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHEN ZHEN RONG FENG TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CALIBEUR INDUSTRIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMBEI TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ENVISEN INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN FINICARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUZHONG TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SONIDA DIGITAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN URION TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XUNWEI INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YI FANG BLISTER PACKAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN YOUKEDE MEDICAL EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SMART TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MELODICARE MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
T&R BIOFAB CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRULY INSTRUMENT LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TYTO CARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNI-TREND TECHNOLOGY (CHINA) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNI-TREND TECHNOLOGY(CHINA) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WELLVII INC
  SUBSTANTIALLY EQUIVALENT 1
WENZHOU YOSUN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
XIAMEN INTRETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG RONGSHENG INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN JINLI ELECTRONIC WEIGHING  EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 52 52
2020 53 53
2021 115 115
2022 142 142
2023 101 101
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 263 263
False Negative Result 95 95
Insufficient Information 59 59
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Use of Device Problem 19 19
Adverse Event Without Identified Device or Use Problem 19 19
Low Readings 19 19
Patient Device Interaction Problem 10 10
Appropriate Term/Code Not Available 8 8
High Readings 7 7
Improper or Incorrect Procedure or Method 6 6
Incorrect Measurement 6 6
Output Problem 6 6
Low Test Results 4 4
High Test Results 3 3
Device Damaged Prior to Use 3 3
Defective Device 3 3
Device Sensing Problem 3 3
Difficult to Insert 3 3
Labelling, Instructions for Use or Training Problem 2 2
Material Fragmentation 2 2
Break 2 2
Migration or Expulsion of Device 2 2
Overheating of Device 2 2
Loss of Power 2 2
Loose or Intermittent Connection 2 2
Unable to Obtain Readings 2 2
Temperature Problem 2 2
Explosion 2 2
Detachment of Device or Device Component 2 2
Incomplete or Inadequate Connection 1 1
Device Fell 1 1
Structural Problem 1 1
Failure to Advance 1 1
No Apparent Adverse Event 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Device Alarm System 1 1
Component Missing 1 1
Electromagnetic Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Moisture or Humidity Problem 1 1
Application Program Problem 1 1
Battery Problem 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Positioning Failure 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 276 276
Fever 112 112
No Known Impact Or Consequence To Patient 25 25
Insufficient Information 17 17
No Consequences Or Impact To Patient 10 10
Superficial (First Degree) Burn 6 6
Alteration in Body Temperature 5 5
Seizures 5 5
Perforation 4 4
Foreign Body In Patient 4 4
Hemorrhage/Bleeding 3 3
Hypothermia 3 3
Burn(s) 3 3
Burning Sensation 3 3
Injury 3 3
Laceration(s) of Esophagus 3 3
Blood Loss 3 3
Pain 2 2
Anxiety 2 2
Distress 2 2
Fistula 2 2
Gastritis 2 2
Caustic/Chemical Burns 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Convulsion/Seizure 2 2
Bronchial Hemorrhage 1 1
Epistaxis 1 1
Gastroesophageal Burn 1 1
Unspecified Gastrointestinal Problem 1 1
Unspecified Kidney or Urinary Problem 1 1
Blister 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
No Code Available 1 1
Hematoma 1 1
Death 1 1
Arrhythmia 1 1
Asthma 1 1
Bacterial Infection 1 1
Unspecified Infection 1 1
Irritation 1 1
Nausea 1 1
Oversedation 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Pneumonia 1 1
Discomfort 1 1
Sepsis 1 1
Skin Discoloration 1 1
Tachycardia 1 1
Malaise 1 1
Abdominal Distention 1 1
No Patient Involvement 1 1
Nasal Obstruction 1 1
Shaking/Tremors 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Feb-04-2020
2 Welch Allyn Inc II Sep-16-2021
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