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
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	46
2021	59	59
2022	37	40
2023	165	165
2024	138	138
2025	123	123

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	212	214
Mechanical Problem	42	42
Appropriate Term/Code Not Available	34	34
Insufficient Information	34	34
Break	30	31
Adverse Event Without Identified Device or Use Problem	28	29
Use of Device Problem	23	23
Defective Component	19	19
Sharp Edges	11	11
Material Integrity Problem	10	10
Fracture	9	9
Mechanics Altered	9	9
Improper or Incorrect Procedure or Method	7	7
Device Slipped	7	7
Human-Device Interface Problem	7	7
Unintended Movement	7	7
Component Missing	6	6
Loose or Intermittent Connection	4	5
Material Split, Cut or Torn	4	4
Installation-Related Problem	4	4
Misassembly by Users	4	4
Solder Joint Fracture	4	4
Device Tipped Over	3	3
Product Quality Problem	3	5
Patient Device Interaction Problem	3	3
Material Twisted/Bent	3	3
Unintended System Motion	2	2
Electromagnetic Interference	2	3
Protective Measures Problem	2	2
Material Separation	2	2
Device Unsafe to Use in Environment	2	2
Fail-Safe Problem	2	2
Material Fragmentation	2	2
Degraded	2	2
Misassembled During Installation	2	2
Scratched Material	2	2
Defective Device	2	2
Patient-Device Incompatibility	2	2
Difficult to Fold, Unfold or Collapse	2	2
Device Damaged Prior to Use	2	2
Physical Resistance/Sticking	2	2
Compatibility Problem	2	2
Unstable	2	2
Inadequate Instructions for Healthcare Professional	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Misassembly During Maintenance/Repair	1	1
Unintended Deflation	1	1
Material Deformation	1	1
Device Fell	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	244	246
Insufficient Information	84	85
Bone Fracture(s)	60	60
Fall	54	54
Laceration(s)	45	45
Limb Fracture	16	16
Bruise/Contusion	15	15
Head Injury	14	14
Pain	12	12
Abrasion	8	8
Swelling/ Edema	7	7
Hip Fracture	6	6
Hematoma	6	6
Concussion	6	6
Death	5	8
Brain Injury	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Musculoskeletal problem	4	4
Multiple Fractures	4	4
Loss of consciousness	3	3
Pressure Sores	3	3
Crushing Injury	3	3
Tooth Fracture	3	3
Hemorrhage/Bleeding	2	2
Convulsion/Seizure	2	2
Skin Tears	2	2
Neck Stiffness	2	2
Unspecified Tissue Injury	2	2
Muscle/Tendon Damage	2	2
Hyperextension	2	2
Strangulation	2	2
Burn(s)	2	2
Post Traumatic Wound Infection	2	2
Easy Bruising	2	2
Damage to Ligament(s)	2	2
Confusion/ Disorientation	1	1
No Known Impact Or Consequence To Patient	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
Spinal Column Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Suture Abrasion	1	1
Myalgia	1	1
Rupture	1	1
No Information	1	1

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