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
chamber, hyperbaric
Product Code
CBF
Regulation Number
868.5470
Device Class
2
Premarket Reviews
Manufacturer
Decision
OXAVITA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
US HYPERBARIC NETWORK
SUBSTANTIALLY EQUIVALENT
1
1. K220290
Revitalair 430+
MDR Year
MDR Reports
MDR Events
2019
3
3
2020
4
4
2021
6
6
2022
9
9
2023
13
13
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
11
11
Decrease in Pressure
4
4
Use of Device Problem
3
3
Mechanical Problem
3
3
Fail-Safe Problem
2
2
Key or Button Unresponsive/not Working
2
2
Output Problem
1
1
Protective Measures Problem
1
1
Material Split, Cut or Torn
1
1
Sharp Edges
1
1
Fail-Safe Did Not Operate
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Align
1
1
Contamination /Decontamination Problem
1
1
Activation, Positioning or Separation Problem
1
1
Product Quality Problem
1
1
Unexpected Therapeutic Results
1
1
Complete Blockage
1
1
Electrical /Electronic Property Problem
1
1
Emergency Power Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
20
20
Convulsion/Seizure
3
3
Death
2
2
Dyspnea
2
2
Headache
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Myocardial Infarction
1
1
Pneumothorax
1
1
Transient Ischemic Attack
1
1
No Consequences Or Impact To Patient
1
1
Low Oxygen Saturation
1
1
No Patient Involvement
1
1
Superficial (First Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Partial thickness (Second Degree) Burn
1
1
Neuralgia
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Total Hearing Loss
1
1
Insufficient Information
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Cardiopulmonary Arrest
1
1
-
-