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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transport, patient, powered
Product CodeILK
Regulation Number 890.5150
Device Class 2


Premarket Reviews
ManufacturerDecision
AAT ALBER ANTRIEBSTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
BRUNO INDEPENDENT LIVING AIDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOVEROUND CORP.
  SUBSTANTIALLY EQUIVALENT 1
SANO TRANSPORTGERAETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT HARMAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
THYSSENKRUPP ACCESSIBILITY B.V.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Positioning 3 3
Protective Measures Problem 2 2
Difficult to Fold, Unfold or Collapse 2 2
Insufficient Information 2 2
Device Handling Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Mechanical Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Death 2 2
Fall 1 1
Unspecified Musculoskeletal problem 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Savaria Concord Lifts, Inc. II Apr-27-2017
2 Savaria Concord Lifts, Inc. II Apr-26-2017
3 Stryker Medical Division of Stryker Corporation II Aug-22-2012
4 ThyssenKrupp Access Corp II Dec-18-2012
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