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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device components, wheelchair
Product CodeKNN
Regulation Number 890.3920
Device Class 1


Premarket Reviews
ManufacturerDecision
KINETIC INNOVATIVE SEATING SYSTEM LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 16 16
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 7 7
Insufficient Information 6 6
Degraded 3 3
Fluid/Blood Leak 2 2
Improper or Incorrect Procedure or Method 2 2
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Misassembly by Users 1 1
Off-Label Use 1 1
Material Rupture 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 17 17
Fall 2 2
Bone Fracture(s) 1 1
Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aquila Corporation II Sep-18-2023
2 mo-Vis BVBA II Jan-11-2024
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