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
exerciser, powered
Product Code
BXB
Regulation Number
890.5380
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
6
6
2016
6
6
2017
4
4
2018
2
2
2019
2
2
2021
2
2
2023
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4
4
Mechanics Altered
4
4
Insufficient Information
4
4
Use of Device Problem
4
4
Physical Resistance/Sticking
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Sparking
2
2
Failure to Power Up
2
2
Detachment Of Device Component
2
2
Fire
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Nonstandard Device
1
1
Loss of Power
1
1
Material Separation
1
1
Device Inoperable
1
1
Calibration Error
1
1
Failure to Auto Stop
1
1
Failure to Shut Off
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Device Fell
1
1
Complete Loss of Power
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
11
11
Bone Fracture(s)
6
6
Laceration(s)
4
4
Injury
4
4
Insufficient Information
3
3
No Known Impact Or Consequence To Patient
3
3
Skin Tears
2
2
Swelling
2
2
Pain
2
2
Bruise/Contusion
2
2
Fall
2
2
Hemorrhage/Bleeding
2
2
Burn(s)
1
1
Emotional Changes
1
1
Head Injury
1
1
Headache
1
1
Hematoma
1
1
Perforation
1
1
Shock
1
1
No Consequences Or Impact To Patient
1
1
Physical Entrapment
1
1
Disability
1
1
Respiratory Acidosis
1
1
Ambulation Difficulties
1
1
No Patient Involvement
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Accelerated Care Plus Corporation
II
Jul-31-2013
2
Alter-G, Incorporated
II
Aug-16-2011
3
BioMotion Medical Systems, LLC
II
Dec-20-2012
4
Hocoma AG
II
Jan-07-2010
5
MOTEK MEDICAL B.V.
II
May-27-2020
-
-