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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 4 4
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3 3
Failure to Power Up 2 2
Break 2 2
Use of Device Problem 2 2
Complete Loss of Power 1 1
Insufficient Device Problem Information 1 1
Detachment of Device or Device Component 1 1
Off-Label Use 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Sparking 1 1
Mechanical Problem 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
Unspecified Tissue Injury 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Pain 2 2
Limb Fracture 1 1
Fall 1 1
Bone Fracture(s) 1 1
Ambulation or Postural Difficulties 1 1
Failure of Implant 1 1
Respiratory Acidosis 1 1
Head Injury 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Btt Health Gmbh II Sep-17-2024
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