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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device exerciser, measuring
Product CodeISD
Regulation Number 890.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
LODE B.V.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SLEEP MODUS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 1 1
2018 2 2
2019 1 1
2021 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 1 1
Corroded 1 1
Defective Component 1 1
Fracture 1 1
Device Operates Differently Than Expected 1 1
Detachment of Device or Device Component 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Limb Fracture 4 4
Partial thickness (Second Degree) Burn 2 2
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BTE Technologies, Inc. II Jul-06-2015
2 MedX Holdings, Inc. II Jan-07-2015
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