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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, physiological signal, radiofrequency
Product CodeDRG
Regulation Number 870.2910
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOINTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLNTELLISENSE INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAVEHEART WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOLINE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ELASTIC CARE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRAFTWORX, INC. DBA ALIO
  SUBSTANTIALLY EQUIVALENT 1
LIFESIGNALS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MORTARA INSTRUMENT INC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SIBEL HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 2
SIBEL INC.
  SUBSTANTIALLY EQUIVALENT 2
SIGKNOW BIOMEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITALCONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 4
VITLS INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVALNK, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVIFY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 70 70
2020 82 82
2021 107 107
2022 44 44
2023 19 19
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 218 218
Output Problem 34 34
Intermittent Communication Failure 21 21
Thermal Decomposition of Device 19 19
Computer Software Problem 17 17
Signal Artifact/Noise 14 14
Application Program Problem 11 11
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Power Problem 7 7
Protective Measures Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Power Up 6 6
Computer System Security Problem 5 5
Device Alarm System 5 5
Incomplete or Inadequate Connection 5 5
Unintended Application Program Shut Down 4 4
No Display/Image 4 4
Loss of Power 3 3
Data Problem 3 3
Computer Operating System Problem 3 3
Sparking 3 3
Smoking 2 2
No Audible Alarm 2 2
Connection Problem 2 2
Display or Visual Feedback Problem 2 2
Operating System Becomes Nonfunctional 2 2
Appropriate Term/Code Not Available 2 2
Temperature Problem 2 2
Wireless Communication Problem 1 1
Defective Component 1 1
Patient Data Problem 1 1
Image Display Error/Artifact 1 1
High Readings 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
Application Program Problem: Parameter Calculation Error 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Filtration Problem 1 1
Overheating of Device 1 1
Unintended Electrical Shock 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Read Input Signal 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 253 253
No Consequences Or Impact To Patient 60 60
No Known Impact Or Consequence To Patient 49 49
No Information 6 6
Insufficient Information 5 5
Death 3 3
No Patient Involvement 3 3
Contact Dermatitis 2 2
Partial thickness (Second Degree) Burn 2 2
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Hypoxia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biointellisense Inc. II Aug-14-2024
2 Nihon Kohden America Inc II Mar-02-2021
3 Vitalconnect Inc. II Jul-10-2020
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