TPLC - Total Product Life Cycle

• Device: wheelchair, mechanical
• Product Code: IOR
• Regulation Number: 890.3850
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
BRODA SEATING (BRODA LP)
	SUBSTANTIALLY EQUIVALENT	1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HORIZON MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KI MOBILITY LLC
	SUBSTANTIALLY EQUIVALENT	2
LEGGERO LLC
	SUBSTANTIALLY EQUIVALENT	1
LICHTMEGA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOBILITY SOURCE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
PANTHERA AB
	SUBSTANTIALLY EQUIVALENT	1
POWER PLUS MOBILITY
	SUBSTANTIALLY EQUIVALENT	1
RGK WHEELCHAIRS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ROUGHRIDER AMERICA LLC
	SUBSTANTIALLY EQUIVALENT	1
ROWHEELS INC.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TURBO WHEELCHAIR CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	53	53
2020	43	43
2021	59	59
2022	37	37
2023	165	165
2024	79	79

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	91	91
Break	34	34
Adverse Event Without Identified Device or Use Problem	33	33
Mechanical Problem	32	32
Appropriate Term/Code Not Available	29	29
Insufficient Information	28	28
Use of Device Problem	22	22
Defective Component	17	17
Fracture	12	12
Device Slipped	9	9
Material Integrity Problem	9	9
Mechanics Altered	9	9
Sharp Edges	9	9
Unintended Movement	8	8
Improper or Incorrect Procedure or Method	8	8
Human-Device Interface Problem	6	6
Component Missing	6	6
Material Split, Cut or Torn	5	5
Solder Joint Fracture	5	5
Device Tipped Over	4	4
Misassembly by Users	4	4
Loose or Intermittent Connection	4	4
Material Twisted/Bent	4	4
Installation-Related Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Device Fell	3	3
Patient Device Interaction Problem	3	3
Protective Measures Problem	3	3
Material Fragmentation	3	3
Misassembly During Maintenance/Repair	3	3
Product Quality Problem	3	3
Difficult to Fold, Unfold or Collapse	2	2
Device Unsafe to Use in Environment	2	2
Electromagnetic Interference	2	2
Unintended System Motion	2	2
Material Separation	2	2
Fail-Safe Problem	2	2
Misassembled During Installation	2	2
Scratched Material	2	2
Crack	2	2
Physical Resistance/Sticking	2	2
Entrapment of Device	2	2
Compatibility Problem	2	2
Unstable	2	2
Retraction Problem	1	1
Material Protrusion/Extrusion	1	1
Missing Information	1	1
No Apparent Adverse Event	1	1
Degraded	1	1
Inadequate Instructions for Healthcare Professional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	108	108
Insufficient Information	79	79
Bone Fracture(s)	68	68
Fall	58	58
Laceration(s)	47	47
Head Injury	18	18
Bruise/Contusion	13	13
Limb Fracture	11	11
Pain	10	10
Death	9	9
Abrasion	8	8
Hip Fracture	7	7
Hematoma	7	7
Swelling/ Edema	6	6
Injury	5	5
Brain Injury	5	5
Pressure Sores	4	4
Crushing Injury	4	4
No Known Impact Or Consequence To Patient	3	3
Post Traumatic Wound Infection	3	3
Tooth Fracture	3	3
Loss of consciousness	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Damage to Ligament(s)	3	3
Multiple Fractures	2	2
Neck Stiffness	2	2
Easy Bruising	2	2
Tissue Damage	2	2
Spinal Column Injury	2	2
Joint Dislocation	2	2
Unspecified Tissue Injury	2	2
Burn(s)	2	2
Muscle/Tendon Damage	2	2
Concussion	2	2
Hyperextension	2	2
Unspecified Respiratory Problem	1	1
Partial thickness (Second Degree) Burn	1	1
Skin Tears	1	1
Caustic/Chemical Burns	1	1
Shaking/Tremors	1	1
Inadequate Pain Relief	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Eye Injury	1	1
Abscess	1	1
Nervous System Injury	1	1
Full thickness (Third Degree) Burn	1	1
Strangulation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Intracranial Hemorrhage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	TiSport, Llc	II	Nov-18-2021
2	TiSport, Llc	II	Aug-20-2019