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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
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 3
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 2
VITLS INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVALNK, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVIFY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 82 82
2021 107 107
2022 43 43
2023 19 19
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 185 185
Output Problem 34 34
Intermittent Communication Failure 20 20
Computer Software Problem 18 18
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
No Display/Image 5 5
Incomplete or Inadequate Connection 5 5
Computer System Security Problem 5 5
Device Alarm System 4 4
Unintended Application Program Shut Down 4 4
Display or Visual Feedback Problem 4 4
Computer Operating System Problem 3 3
Data Problem 3 3
Loss of Power 3 3
No Audible Alarm 2 2
Failure to Power Up 2 2
Appropriate Term/Code Not Available 2 2
Connection Problem 2 2
Failure to Read Input Signal 1 1
Operating System Becomes Nonfunctional 1 1
Filtration Problem 1 1
Defective Component 1 1
Patient Data Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
No Apparent Adverse Event 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Delayed Program or Algorithm Execution 1 1
Overheating of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Device Displays Incorrect Message 1 1
Biocompatibility 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 255 255
No Known Impact Or Consequence To Patient 24 24
No Consequences Or Impact To Patient 23 23
Insufficient Information 6 6
Death 3 3
Contact Dermatitis 2 2
Partial thickness (Second Degree) Burn 2 2
No Patient Involvement 1 1
Unspecified Tissue Injury 1 1
Hypoxia 1 1
Tissue Damage 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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