TPLC - Total Product Life Cycle

• Device: wheelchair, standup
• Regulation Description: Standup wheelchair.
• Product Code: IPL
• Regulation Number: 890.3900
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACTION MANUFACTURING, INC.
	SUBSTANTIALLY EQUIVALENT	1
POWERBASETEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ZUOWEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	4	4
2022	3	3
2023	9	9
2024	6	6
2025	5	5
2026	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Use of Device Problem	7	7
Unintended Movement	7	7
Unintended System Motion	6	6
Insufficient Device Problem Information	2	2
Device Handling Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Material Integrity Problem	2	2
Electrical /Electronic Property Problem	2	2
Unexpected Shutdown	1	1
Unintended Collision	1	1
Complete Loss of Power	1	1
Power Problem	1	1
Detachment of Device or Device Component	1	1
Installation-Related Problem	1	1
Break	1	1
Mechanical Jam	1	1
Material Protrusion/Extrusion	1	1
Misassembled During Installation	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bone Fracture(s)	27	27
Limb Fracture	14	14
Multiple Fractures	8	8
No Clinical Signs, Symptoms or Conditions	3	3
Laceration(s)	2	2
Hip Fracture	2	2
Swelling/ Edema	1	1
Abrasion	1	1
Pressure Sore/Ulcer	1	1
Unspecified Musculoskeletal problem	1	1
Bruise/Contusion	1	1
Ulcer	1	1
Tissue Breakdown	1	1