TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
AIKIN HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BRODA SEATING (BRODA LP)
	SUBSTANTIALLY EQUIVALENT	1
COLUMBIA MEDICAL MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	1
CONVAID PRODUCTS LLC.
	SUBSTANTIALLY EQUIVALENT	1
CONVAID PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
DALTON INSTRUMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
DANYANG COMED HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
DANYANG SUNCO MACHINERY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DANYANG SUNTEC AUTO PARTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN SHUNDE JAEYONG HARDWARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FREE WHEELCHAIR MISSION
	SUBSTANTIALLY EQUIVALENT	3
FREEDOM DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUTURE MOBILITY HEALTHCARE INC.
	SUBSTANTIALLY EQUIVALENT	4
GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUNNELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
HARMONY HILL INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
HARRIS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ICON WHEELCHAIRS INC
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
JCM SEATING SOLUTIONS LTD
	SUBSTANTIALLY EQUIVALENT	1
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HEALTHY MEDICAL EQUIPMENT CO;LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HEALTHY WAY MEDICAL EQUIPMENT 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
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGYIN NEWRISE MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KI MOBILITY LLC
	SUBSTANTIALLY EQUIVALENT	2
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
LEGGERO LLC
	SUBSTANTIALLY EQUIVALENT	1
LICHTMEGA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL REHAB PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERITS HEALTHCARE INDUSTRIES (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOBILITY SOURCE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MODERN REHABILITATION SOLUTIONS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MOTION COMPOSITES
	SUBSTANTIALLY EQUIVALENT	3
NINGBO LECOUNT 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
OTTO BOCK HEALTHCARE, LP
	SUBSTANTIALLY EQUIVALENT	2
P.D.G., INC.
	SUBSTANTIALLY EQUIVALENT	1
PANTHERA AB
	SUBSTANTIALLY EQUIVALENT	1
PANTHERA PRODUCTION AB
	SUBSTANTIALLY EQUIVALENT	1
PATMONT MOTOR WERKS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PDG PRODUCT DESIGN GROUP, INC
	SUBSTANTIALLY EQUIVALENT	1
PDG PRODUCT DESIGN GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
PINGDINGSHAN SHENXING HEALTHCARE TECHNOLOGY CO., L
	SUBSTANTIALLY EQUIVALENT	1
POWER PLUS MOBILITY
	SUBSTANTIALLY EQUIVALENT	1
PRIDE MOBILITY PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
PROACTIVE COMFORT, LLC
	SUBSTANTIALLY EQUIVALENT	1
R82 A/S
	SUBSTANTIALLY EQUIVALENT	2
REHAMED INTL. LLC.
	SUBSTANTIALLY EQUIVALENT	1
RGK WHEELCHAIRS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ROGUE WHEELCHAIRS INC
	SUBSTANTIALLY EQUIVALENT	1
ROUGHRIDER AMERICA LLC
	SUBSTANTIALLY EQUIVALENT	1
ROWHEELS INC.
	SUBSTANTIALLY EQUIVALENT	1
RUPIANI
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SUNRISE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SUNRISE MEDICAL (US) LLC
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU KD MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TURBO WHEELCHAIR CO., INC.
	SUBSTANTIALLY EQUIVALENT	1
VALENTINE INTL. LTD.
	SUBSTANTIALLY EQUIVALENT	1
WARDRAY PREMISE LTD
	SUBSTANTIALLY EQUIVALENT	1
WHIRLWIND WHEELCHAIR INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
WINNER SG PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG JIAFENG ELECTRICAL & MECHANIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD
	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
2014	5082	5082
2015	4472	4472
2016	1860	1860
2017	49	49
2018	58	58
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
Break	4734	4734
Bent	1367	1367
Device Operates Differently Than Expected	844	844
Mechanical Problem	729	729
Detachment Of Device Component	583	583
Crack	580	580
Device Slipped	562	562
Torn Material	347	347
Naturally Worn	328	328
Unstable	324	324
Out-Of-Box Failure	280	280
Component Missing	242	242
Component Falling	231	231
Loose or Intermittent Connection	220	220
Material Integrity Problem	206	206
Mechanics Altered	185	185
Detachment of Device or Device Component	185	185
Material Deformation	168	168
Product Quality Problem	132	132
Device Inoperable	99	99
Unintended Movement	83	83
Adverse Event Without Identified Device or Use Problem	76	76
Sticking	74	74
Material Separation	73	73
Noise, Audible	72	72
Improper or Incorrect Procedure or Method	66	66
Stretched	66	66
Split	66	66
Insufficient Information	59	59
Appropriate Term/Code Not Available	52	52
Device Tipped Over	43	43
Device Dislodged or Dislocated	41	41
Malposition of Device	38	38
Use of Device Problem	38	38
Material Frayed	37	37
Fracture	36	36
Defective Component	35	35
Collapse	33	33
Positioning Problem	33	33
Peeled/Delaminated	32	32
Tear, Rip or Hole in Device Packaging	31	31
Defective Device	31	31
Unraveled Material	30	30
Hole In Material	30	30
Connection Problem	29	29
Failure to Align	29	29
Fitting Problem	27	27
Mechanical Jam	24	24
Leak/Splash	22	22
Device Damaged Prior to Use	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	8700	8700
No Consequences Or Impact To Patient	1386	1386
No Information	895	895
Fall	287	287
Bone Fracture(s)	123	123
No Clinical Signs, Symptoms or Conditions	108	108
Injury	103	103
Laceration(s)	86	86
Insufficient Information	79	79
Bruise/Contusion	63	63
Head Injury	48	48
Pain	40	40
No Patient Involvement	39	39
Abrasion	19	19
No Code Available	19	19
Discomfort	18	18
Complaint, Ill-Defined	16	16
Pressure Sores	13	13
Death	13	13
Tissue Damage	12	12
Limb Fracture	11	11
Hip Fracture	11	11
Physical Entrapment	10	10
Skin Tears	8	8
Hematoma	8	8
Hemorrhage/Bleeding	8	8
Concussion	8	8
Brain Injury	7	7
Loss of consciousness	7	7
Fracture, Arm	7	7
Swelling/ Edema	6	6
Crushing Injury	6	6
Swelling	6	6
Seizures	5	5
Headache	5	5
Post Traumatic Wound Infection	5	5
Tooth Fracture	4	4
Joint Dislocation	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Damage to Ligament(s)	3	3
Muscle Spasm(s)	3	3
Burn(s)	3	3
Unspecified Tissue Injury	2	2
Muscle/Tendon Damage	2	2
Abscess	2	2
Hyperextension	2	2
Valvular Stenosis	2	2
Partial thickness (Second Degree) Burn	2	2
Hyperglycemia	2	2
Neck Stiffness	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	CHENICA INC.	II	Feb-13-2013
2	Gunnell, Inc.	II	Jan-25-2012
3	Invacare Corporation	II	Jan-08-2014
4	Invacare Corporation	II	Feb-04-2013
5	Invacare Corporation	II	Nov-25-2009
6	Karman Healthcare Inc	II	Feb-27-2016
7	Pdg Product Design Group Inc	II	Sep-24-2014
8	Silver Star Brands	II	Nov-14-2014
9	Snug Seat Inc	II	Dec-16-2014
10	Sunrise Medical Inc	II	Dec-28-2010
11	Sunrise Medical (US) LLC	II	Jul-25-2016
12	Sunrise Medical (US) LLC	II	Aug-26-2015
13	Sunrise Medical (US) LLC	II	Jan-27-2015
14	Sunrise Medical (US) LLC	II	Dec-05-2013
15	Sunrise Medical (US) LLC	II	Jul-31-2012
16	Sunrise Medical (US) LLC	II	Feb-24-2012
17	TiSport, Llc	II	Nov-18-2021
18	TiSport, Llc	II	Aug-20-2019
19	TiSport, Llc	II	Sep-07-2011