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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, powered
Regulation Description Powered exercise equipment.
Product CodeBXB
Regulation Number 890.5380
Device Class 1

MDR Year MDR Reports MDR Events
2016 6 6
2017 4 4
2018 2 2
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Handpiece 2 2
Break 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Failure to Auto Stop 1 1
Mechanics Altered 1 1
Calibration Error 1 1
Detachment Of Device Component 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Device Inoperable 1 1
Device Fell 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 4 4
No Known Impact Or Consequence To Patient 3 3
Laceration(s) 2 2
Pain 1 1
Bruise/Contusion 1 1
Bone Fracture(s) 1 1
No Patient Involvement 1 1
Burn(s) 1 1
Swelling 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MOTEK MEDICAL B.V. II May-27-2020
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