Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
transmitters and receivers, physiological signal, radiofrequency
Regulation Description
Radiofrequency physiological signal transmitter and receiver.
Product Code
DRG
Regulation Number
870.2910
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K211305
ANNE One
2. K221530
ANNE Pediatric
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
Data Problem
3
3
Computer Operating System Problem
3
3
Loss of Power
3
3
Connection Problem
2
2
Failure to Power Up
2
2
No Audible Alarm
2
2
Appropriate Term/Code Not Available
2
2
Application Program Problem: Parameter Calculation Error
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Operating System Becomes Nonfunctional
1
1
Temperature Problem
1
1
Failure to Read Input Signal
1
1
Device Displays Incorrect Message
1
1
Delayed Program or Algorithm Execution
1
1
Filtration Problem
1
1
Defective Component
1
1
Biocompatibility
1
1
Patient Data Problem
1
1
No Apparent Adverse Event
1
1
Improper or Incorrect Procedure or Method
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Overheating of Device
1
1
Labelling, Instructions for Use or Training 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
Tissue Damage
1
1
Unspecified Tissue Injury
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
-
-