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TPLC
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show TPLC since
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Device
wheelchair, standup
Product Code
IPL
Regulation Number
890.3900
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACTION MANUFACTURING INC.
SUBSTANTIALLY EQUIVALENT
2
COMFORT ORTHOPEDIC CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
DAVISMADE, INC.
SUBSTANTIALLY EQUIVALENT
1
E-TENG TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
MATIA ROBOTICS (US) INC
SUBSTANTIALLY EQUIVALENT
1
MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN VE TIC.A.S
SUBSTANTIALLY EQUIVALENT
1
MAX MOBILITY, LLC
SUBSTANTIALLY EQUIVALENT
1
MOTION CONCEPTS
SUBSTANTIALLY EQUIVALENT
1
PERMOBIL AB
SUBSTANTIALLY EQUIVALENT
2
POWERBASETEC GMBH
SUBSTANTIALLY EQUIVALENT
1
SUNRISE MEDICAL (US) LLC
SUBSTANTIALLY EQUIVALENT
1
UPNRIDE ROBOTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
3
3
2018
1
1
2019
1
1
2021
4
4
2022
3
3
2023
9
9
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6
6
Unintended Movement
6
6
Mechanical Problem
6
6
Unintended System Motion
4
4
Use of Device Problem
4
4
Material Integrity Problem
3
3
Insufficient Information
2
2
Improper or Incorrect Procedure or Method
2
2
Break
2
2
Misassembled During Installation
1
1
Scratched Material
1
1
Unexpected Shutdown
1
1
Leak/Splash
1
1
Device Fell
1
1
Electrical /Electronic Property Problem
1
1
Mechanical Jam
1
1
Material Separation
1
1
Material Protrusion/Extrusion
1
1
Labelling, Instructions for Use or Training Problem
1
1
Installation-Related Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Bone Fracture(s)
21
21
Limb Fracture
8
8
Multiple Fractures
6
6
No Known Impact Or Consequence To Patient
2
2
Hip Fracture
1
1
Unspecified Musculoskeletal problem
1
1
Abrasion
1
1
Injury
1
1
Laceration(s)
1
1
Swelling/ Edema
1
1
Ulcer
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
The Standing Company
II
Feb-19-2014
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