TPLC - Total Product Life Cycle

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Device	wheelchair, mechanical
Regulation Description	Mechanical wheelchair.
Definition	A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.
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
EMPOWER RIDE, LLC
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN NANHAI HONGCHEN MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN SHUNKANGDA MEDICAL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., , LTD.
	SUBSTANTIALLY EQUIVALENT	3
KARMA MOBILITY 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	3
PANTHERA AB
	SUBSTANTIALLY EQUIVALENT	1
POWER PLUS MOBILITY
	SUBSTANTIALLY EQUIVALENT	1
ROUGHRIDER AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
TURBO WHEELCHAIR CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	214	216
Mechanical Problem	54	54
Appropriate Term/Code Not Available	34	34
Insufficient Information	33	33
Break	30	31
Adverse Event Without Identified Device or Use Problem	23	23
Use of Device Problem	22	22
Defective Component	19	19
Material Integrity Problem	12	12
Sharp Edges	10	10
Mechanics Altered	9	9
Fracture	8	8
Improper or Incorrect Procedure or Method	7	7
Human-Device Interface Problem	7	7
Device Slipped	6	6
Material Twisted/Bent	6	6
Component Missing	6	6
No Apparent Adverse Event	5	5
Misassembly by Users	4	4
Defective Device	4	4
Loose or Intermittent Connection	3	4
Material Split, Cut or Torn	3	3
Device Damaged Prior to Use	3	3
Unintended Movement	3	3
Patient Device Interaction Problem	3	3
Electromagnetic Interference	2	3
Protective Measures Problem	2	2
Installation-Related Problem	2	2
Device Unsafe to Use in Environment	2	2
Solder Joint Fracture	2	2
Fail-Safe Problem	2	2
Material Fragmentation	2	2
Degraded	2	2
Misassembled During Installation	2	2
Scratched Material	2	2
Patient-Device Incompatibility	2	2
Difficult to Fold, Unfold or Collapse	2	2
Physical Resistance/Sticking	2	2
Device Tipped Over	2	2
Compatibility Problem	2	2
Unintended Ejection	1	1
Ejection Problem	1	1
Unintended Deflation	1	1
Misassembly During Maintenance/Repair	1	1
Device Fell	1	1
Material Deformation	1	1
Separation Failure	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	256	258
Insufficient Information	91	92
Bone Fracture(s)	57	57
Fall	54	54
Laceration(s)	39	39
Limb Fracture	16	16
Pain	14	14
Bruise/Contusion	12	12
Head Injury	12	12
Hip Fracture	9	9
Abrasion	9	9
Swelling/ Edema	7	7
Concussion	6	6
Hematoma	5	5
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Musculoskeletal problem	4	4
Multiple Fractures	4	4
Brain Injury	3	3
Crushing Injury	3	3
Strangulation	3	3
Pressure Sores	2	2
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
Burn(s)	2	2
Easy Bruising	2	2
Damage to Ligament(s)	2	2
Neck Pain	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Nerve Damage	1	1
Loss of Range of Motion	1	1
Intracranial Hemorrhage	1	1
Confusion/ Disorientation	1	1
Post Traumatic Wound Infection	1	1
Spinal Column Injury	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Abscess	1	1
Eye Injury	1	1
Tooth Fracture	1	1
Myalgia	1	1
Shaking/Tremors	1	1
Rupture	1	1
Emotional Changes	1	1
Skin Infection	1	1
Syncope/Fainting	1	1

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