TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ANHUI JBH MEDICAL APPARATUS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BOWHEAD DESIGN CORP.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN SHUNKANGDA MEDICAL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KI MOBILITY LLC
	SUBSTANTIALLY EQUIVALENT	2
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
SICHUAN AST MEDICAL EQUIPMENT CO., LTD
	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
2020	43	43
2021	59	59
2022	37	37
2023	165	165
2024	138	138
2025	31	31

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	152	152
Mechanical Problem	33	33
Appropriate Term/Code Not Available	32	32
Break	27	27
Insufficient Information	27	27
Adverse Event Without Identified Device or Use Problem	26	26
Use of Device Problem	20	20
Defective Component	17	17
Sharp Edges	10	10
Fracture	9	9
Mechanics Altered	9	9
Material Integrity Problem	9	9
Unintended Movement	7	7
Device Slipped	6	6
Human-Device Interface Problem	6	6
Component Missing	6	6
Improper or Incorrect Procedure or Method	5	5
Loose or Intermittent Connection	4	4
Installation-Related Problem	4	4
Misassembly by Users	4	4
Solder Joint Fracture	4	4
Patient Device Interaction Problem	3	3
Material Twisted/Bent	3	3
Device Tipped Over	3	3
Material Split, Cut or Torn	3	3
Scratched Material	2	2
Misassembled During Installation	2	2
Material Fragmentation	2	2
Fail-Safe Problem	2	2
Difficult to Fold, Unfold or Collapse	2	2
Device Unsafe to Use in Environment	2	2
Product Quality Problem	2	2
Material Separation	2	2
Physical Resistance/Sticking	2	2
Protective Measures Problem	2	2
Electromagnetic Interference	2	2
Unintended System Motion	2	2
Compatibility Problem	2	2
Unstable	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Inadequate Instructions for Healthcare Professional	1	1
Degraded	1	1
Unintended Deflation	1	1
Device Fell	1	1
Patient-Device Incompatibility	1	1
Separation Failure	1	1
Misassembly During Maintenance/Repair	1	1
Crack	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	177	177
Insufficient Information	84	84
Bone Fracture(s)	55	55
Fall	48	48
Laceration(s)	40	40
Bruise/Contusion	14	14
Head Injury	14	14
Limb Fracture	12	12
Pain	11	11
Abrasion	8	8
Swelling/ Edema	6	6
Hematoma	6	6
Death	5	5
Hip Fracture	5	5
Brain Injury	5	5
Loss of consciousness	3	3
Pressure Sores	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Unspecified Musculoskeletal problem	3	3
Crushing Injury	3	3
Tooth Fracture	3	3
Hemorrhage/Bleeding	2	2
Skin Tears	2	2
Neck Stiffness	2	2
Unspecified Tissue Injury	2	2
Muscle/Tendon Damage	2	2
Hyperextension	2	2
Concussion	2	2
Burn(s)	2	2
Post Traumatic Wound Infection	2	2
Easy Bruising	2	2
Multiple Fractures	2	2
Damage to Ligament(s)	2	2
Spinal Column Injury	1	1
Confusion/ Disorientation	1	1
No Known Impact Or Consequence To Patient	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Intracranial Hemorrhage	1	1
Skin Erosion	1	1
Injury	1	1
Neck Pain	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Nerve Damage	1	1
Loss of Range of Motion	1	1
Strangulation	1	1
Suture Abrasion	1	1
Myalgia	1	1
Rupture	1	1
No Information	1	1
Skull Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	TiSport, Llc	II	Nov-18-2021