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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
Regulation Description Radiofrequency physiological signal transmitter and receiver.
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
IORBIT DIGITAL TECHNOLOGIES PRIVATE LIMITED
  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
THE SCOTTCARE CORPORATION
  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 27 27
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 190 190
Output Problem 36 36
Intermittent Communication Failure 21 21
Computer Software Problem 18 18
Signal Artifact/Noise 14 14
Application Program Problem 11 11
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Power Problem 8 8
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
Display or Visual Feedback Problem 4 4
Unintended Application Program Shut Down 4 4
Data Problem 3 3
Loss of Power 3 3
Computer Operating System Problem 3 3
No Audible Alarm 2 2
Appropriate Term/Code Not Available 2 2
Failure to Power Up 2 2
Connection Problem 2 2
Failure to Read Input Signal 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Operating System Becomes Nonfunctional 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Patient Data Problem 1 1
Intermittent Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Labelling, Instructions for Use or Training Problem 1 1
Overheating of Device 1 1
Application Program Problem: Parameter Calculation Error 1 1
Device Displays Incorrect Message 1 1
Biocompatibility 1 1
Filtration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 263 263
No Known Impact Or Consequence To Patient 24 24
No Consequences Or Impact To Patient 23 23
Insufficient Information 5 5
Death 3 3
Contact Dermatitis 2 2
Partial thickness (Second Degree) Burn 2 2
Tissue Damage 1 1
Unspecified Tissue Injury 1 1
Hypoxia 1 1
No Patient Involvement 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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