• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device treadmill, powered
Regulation Description Powered exercise equipment.
Product CodeIOL
Regulation Number 890.5380
Device Class 1

MDR Year MDR Reports MDR Events
2015 12 12
2016 1 1
2017 4 4
2018 4 4
2019 6 6
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 8 8
Self-Activation or Keying 4 4
Mechanical Problem 2 2
Unintended System Motion 2 2
Improper or Incorrect Procedure or Method 2 2
Unintended Movement 2 2
Failure to Shut Off 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Operating System Becomes Nonfunctional 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Device Emits Odor 1 1
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Capacitor 1 1
Break 1 1
Calibration Error 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 5 5
Fall 5 5
No Patient Involvement 3 3
Abrasion 1 1
Bone Fracture(s) 1 1
Loss of Range of Motion 1 1
Discomfort 1 1
Injury 1 1
Fracture, Arm 1 1
Arthralgia 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare II Jun-22-2015
2 GE Healthcare II Mar-17-2015
3 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Jul-16-2018
-
-