• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device transmitters and receivers, physiological signal, radiofrequency
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOINTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLNTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAVEHEART WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARETAKER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COMARCH HEALTHCARE SA
  SUBSTANTIALLY EQUIVALENT 1
ELASTIC CARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRAFTWORX, INC. DBA ALIO
  SUBSTANTIALLY EQUIVALENT 1
HMICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISANSYS LIFECARE LTD
  SUBSTANTIALLY EQUIVALENT 1
LIFESIGNALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MC10 INC.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT INC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIBEL INC.
  SUBSTANTIALLY EQUIVALENT 2
SIGKNOW BIOMEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNERGEN TECHNOLOGY LABS LLC
  SUBSTANTIALLY EQUIVALENT 1
VITALCONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 4
VITLS INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVALNK, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 166 166
2019 70 70
2020 82 82
2021 107 107
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 214 214
Thermal Decomposition of Device 76 76
Failure to Power Up 47 47
Output Problem 29 29
Adverse Event Without Identified Device or Use Problem 24 24
Intermittent Communication Failure 17 17
Loss of Power 16 16
Computer Software Problem 14 14
Signal Artifact/Noise 11 11
Application Program Problem 10 10
Power Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Smoking 7 7
Overheating of Device 6 6
Appropriate Term/Code Not Available 6 6
Device Issue 6 6
Sparking 5 5
Protective Measures Problem 5 5
Incomplete or Inadequate Connection 5 5
Device Operational Issue 4 4
Break 4 4
Device Alarm System 4 4
Charred 3 3
No Display/Image 3 3
Temperature Problem 3 3
Device Emits Odor 3 3
Radio Signal Problem 3 3
Unintended Application Program Shut Down 3 3
Radiofrequency Interference (RFI) 2 2
Wireless Communication Problem 2 2
Unintended Electrical Shock 2 2
Incorrect Interpretation of Signal 2 2
Operating System Becomes Nonfunctional 2 2
Display or Visual Feedback Problem 2 2
Melted 2 2
Connection Problem 2 2
Device Difficult to Maintain 1 1
Complete Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Electrical /Electronic Property Problem 1 1
Moisture Damage 1 1
Material Rupture 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Biocompatibility 1 1
No Audible Alarm 1 1
Filtration Problem 1 1
Incorrect Measurement 1 1
Patient Data Problem 1 1
Application Program Version or Upgrade Problem 1 1
Application Security Problem 1 1
Device Operates Differently Than Expected 1 1
Material Separation 1 1
Telemetry Discrepancy 1 1
Image Display Error/Artifact 1 1
Application Program Problem: Parameter Calculation Error 1 1
Power Conditioning Problem 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Device Sensing Problem 1 1
Improper Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 208 208
No Known Impact Or Consequence To Patient 183 183
No Consequences Or Impact To Patient 68 68
No Information 27 27
Death 4 4
No Patient Involvement 4 4
Insufficient Information 3 3
Partial thickness (Second Degree) Burn 2 2
Contact Dermatitis 2 2
Electric Shock 2 2
Unspecified Tissue Injury 1 1
Hypoxia 1 1
Shock 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nihon Kohden America Inc II Mar-02-2021
2 Vitalconnect Inc. II Jul-10-2020
-
-