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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
Regulation Description Clinical electronic thermometer.
Product CodeFLL
Regulation Number 880.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOCARE ASIA CORPORATION LTD.
  SUBSTANTIALLY EQUIVALENT 1
COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EASYWELL BIOMEDICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FIAB SPA
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG BIOLIGHT MEDITECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTELLIWORKS LLC
  SUBSTANTIALLY EQUIVALENT 1
INTRINITY GLOBAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KAZ USA, INC., A HELEN OF TROY COMPANY
  SUBSTANTIALLY EQUIVALENT 7
KINSA, INC.
  SUBSTANTIALLY EQUIVALENT 1
K-JUMP HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
K-JUMP HEATH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDISIM LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROLIFE
  SUBSTANTIALLY EQUIVALENT 3
MICROLIFE INTELLECTUAL PROPERTY GMBH
  SUBSTANTIALLY EQUIVALENT 3
NEXMED TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PINGHU SAMA MEDICAL PACKING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADIANT INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RUDOLF RIESTER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CALIBEUR INDUSTRIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JIACOM TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN LAUNCH ELECTRICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN PANGO ELECTRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TECNIMED S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
WITHINGS
  SUBSTANTIALLY EQUIVALENT 1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Thermometer 129
Adverse Event Without Identified Device or Use Problem 77
Insufficient Information 60
False Negative Result 55
Power Problem 34
Battery Problem 27
Product Quality Problem 27
Nonstandard Device 27
Device Issue 22
Invalid Sensing 15
Use of Device Problem 11
Device Operates Differently Than Expected 10
Thermal Decomposition of Device 8
Improper or Incorrect Procedure or Method 7
Device Reprocessing Problem 7
Manufacturing, Packaging or Shipping Problem 6
Low Readings 4
Temperature Problem 4
Low Sensing Threshold 4
Low Test Results 3
Output Problem 3
Device Operational Issue 2
Incorrect, Inadequate or Imprecise Resultor Readings 2
Device Handling Problem 2
Incorrect Measurement 2
Lithium Iodide Battery 1
Break 1
Device Alarm System 1
Computer Software Problem 1
Device Sensing Problem 1
Missing Value Reason 1
Failure to Clean Adequately 1
Calibration Error 1
No Apparent Adverse Event 1
Contamination /Decontamination Problem 1
Display or Visual Feedback Problem 1
Overheating of Device 1
Appropriate Term/Code Not Available 1
Erratic or Intermittent Display 1
Defective Component 1
Total Device Problems 563

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Nov-18-2017
2 Bestmed, LLC II Dec-16-2015
3 Cardinal Health 200, LLC II Feb-04-2020
4 Measurement Specialties Inc II Jan-19-2018
5 Philips Consumer Lifestyle II Feb-22-2018

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