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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
device, biofeedback
Product Code
HCC
Regulation Number
882.5050
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEEPWELL DTX INC.
SUBSTANTIALLY EQUIVALENT
1
EEG SOFTWARE LLC
SUBSTANTIALLY EQUIVALENT
1
GRAYMATTERS HEALTH LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDOTECH A/S
SUBSTANTIALLY EQUIVALENT
1
MYOTRONICS-NOROMED, INC.
SUBSTANTIALLY EQUIVALENT
1
NFANT LABS, LLC
SUBSTANTIALLY EQUIVALENT
1
PALO ALTO HEALTH SCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
2
POWER MEDICAL DEVICES, LLC
SUBSTANTIALLY EQUIVALENT
1
SUNSTAR SUISSE S.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
4
4
2017
3
3
2018
1
1
2019
6
6
2020
1
1
2022
3
3
2023
2
2
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
7
7
Break
3
3
Material Protrusion/Extrusion
2
2
Insufficient Information
2
2
Device Unsafe to Use in Environment
1
1
Material Rupture
1
1
Appropriate Term/Code Not Available
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Nonstandard Device
1
1
Unexpected Therapeutic Results
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Device Interaction Problem
1
1
Scratched Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Sleep Dysfunction
5
5
Visual Disturbances
3
3
Anxiety
3
3
Complaint, Ill-Defined
2
2
Irritability
2
2
Headache
2
2
Brain Injury
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Memory Loss/Impairment
2
2
Cognitive Changes
2
2
Shaking/Tremors
2
2
Confusion/ Disorientation
2
2
No Known Impact Or Consequence To Patient
2
2
Tachycardia
2
2
Foreign Body In Patient
2
2
Reaction
2
2
Muscle Spasm(s)
2
2
Insufficient Information
2
2
Ambulation Difficulties
1
1
Low Blood Pressure/ Hypotension
1
1
Tinnitus
1
1
Cough
1
1
Vascular System (Circulation), Impaired
1
1
Fall
1
1
Pain
1
1
Laceration(s)
1
1
Muscular Rigidity
1
1
Diarrhea
1
1
Depression
1
1
Numbness
1
1
Discomfort
1
1
Injury
1
1
Weakness
1
1
Blinking, Excessive
1
1
Pericardial Effusion
1
1
Disability
1
1
Dizziness
1
1
Fatigue
1
1
Emotional Changes
1
1
Abdominal Pain
1
1
Dysphasia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
EEG Info
II
Dec-17-2012
2
Ondamed Inc
II
May-10-2018
3
Powers Medical Devices, LLC
II
Dec-08-2015
4
RONAN MEDICAL LLC
II
Aug-27-2024
-
-