TPLC - Total Product Life Cycle

• 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	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	6	6
Mechanical Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Unintended System Motion	4	4
Use of Device Problem	4	4
Material Integrity Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Insufficient Information	2	2
Labelling, Instructions for Use or Training Problem	1	1
Break	1	1
Scratched Material	1	1
Leak/Splash	1	1
Unexpected Shutdown	1	1
Mechanical Jam	1	1
Material Separation	1	1
Material Protrusion/Extrusion	1	1
Installation-Related Problem	1	1
Device Fell	1	1
Misassembled During Installation	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bone Fracture(s)	20	20
Limb Fracture	8	8
Multiple Fractures	6	6
No Known Impact Or Consequence To Patient	2	2
Abrasion	1	1
Bruise/Contusion	1	1
Unspecified Musculoskeletal problem	1	1
Swelling/ Edema	1	1
Laceration(s)	1	1
Ulcer	1	1
Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	The Standing Company	II	Feb-19-2014