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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
2021 2 2
2023 15 15
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3 3
Break 2 2
Failure to Power Up 2 2
Sparking 1 1
Fire 1 1
Mechanical Problem 1 1
Off-Label Use 1 1
Output Problem 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Complete Loss of Power 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 4 4
Hemorrhage/Bleeding 2 2
Failure of Implant 1 1
Head Injury 1 1
Respiratory Acidosis 1 1
Fall 1 1
Pain 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1
Headache 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Btt Health Gmbh II Sep-17-2024
2 MOTEK MEDICAL B.V. II May-27-2020
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