TPLC - Total Product Life Cycle

• Device: vehicle, motorized 3-wheeled
• Product Code: INI
• Regulation Number: 890.3800
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCED VEHICLE CONCEPTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
AFIKIM ELECTRIC VEHICLES
	SUBSTANTIALLY EQUIVALENT	1
AGILE DISTRIBUTORS LLC
	SUBSTANTIALLY EQUIVALENT	1
AMIGO MOBILITY INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
ANHUI JBH MEDICAL APPARATUS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BESTEAM TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
C.T.M. HOMECARE PRODUCT, INC.
	SUBSTANTIALLY EQUIVALENT	4
CHIEN TI ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
DONGGUAN PRESTIGE SPORTING GOODS., LTD.
	SUBSTANTIALLY EQUIVALENT	1
EUROGREEN INTERNATIONAL INC
	SUBSTANTIALLY EQUIVALENT	1
EUROGREEN INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
FREERIDER CORP
	SUBSTANTIALLY EQUIVALENT	1
FREERIDER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FREERIDER LUGGIE SCOOTERS INC
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HEARTWAY MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	10
KWANG YANG MOTOR CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LETRIX POWER HANGZHOU PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
MERITS HEALTH PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MOVING LIFE LTD
	SUBSTANTIALLY EQUIVALENT	2
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PRESTIGE SPORTING GOODS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRIDE MOBILITY PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	4
PUC PERFECT UNION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNTECH UK LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SVRC INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TZORA ACTIVE SYSTEMS LTD.
	SUBSTANTIALLY EQUIVALENT	3
WU'S TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WU’S TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YONGKANG DINGCHANG INDUSTRY & TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YONGKANG YILE VEHICLE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
	SUBSTANTIALLY EQUIVALENT	5

MDR Year	MDR Reports	MDR Events
2014	567	567
2015	151	151
2016	76	76
2017	45	45
2018	51	51
2019	25	25
2020	26	26
2021	41	41
2022	41	41
2023	31	31
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	239	239
Break	112	112
Device Stops Intermittently	88	88
Device Operates Differently Than Expected	74	74
Product Quality Problem	71	71
Unintended Movement	67	67
Device Inoperable	58	58
Unstable	43	43
Device Tipped Over	38	38
Fire	35	35
Adverse Event Without Identified Device or Use Problem	35	35
Battery Problem	25	25
Loss of Power	18	18
Mechanical Problem	17	17
Detachment Of Device Component	17	17
Crack	15	15
Insufficient Information	14	14
Component Falling	12	12
Unintended Collision	10	10
Unintended System Motion	9	9
Device Displays Incorrect Message	8	8
Sparking	7	7
Thermal Decomposition of Device	7	7
Naturally Worn	7	7
Noise, Audible	6	6
Overheating of Device	6	6
Charging Problem	6	6
Electronic Property Issue	6	6
Bent	6	6
Device Slipped	5	5
Use of Device Problem	5	5
Detachment of Device or Device Component	5	5
Melted	5	5
Torn Material	5	5
Mechanical Jam	4	4
Sticking	4	4
Improper or Incorrect Procedure or Method	4	4
Device Damaged Prior to Use	3	3
Smoking	3	3
Environmental Compatibility Problem	3	3
Component Missing	3	3
Fluid/Blood Leak	3	3
Electrical /Electronic Property Problem	3	3
Burst Container or Vessel	3	3
Temperature Problem	3	3
Patient Device Interaction Problem	3	3
No Apparent Adverse Event	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Mechanics Altered	2	2
Failure to Charge	2	2
Collapse	2	2
Air Leak	2	2
Computer Software Problem	2	2
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
Entrapment of Device	2	2
Device Unsafe to Use in Environment	2	2
Electrical Shorting	2	2
Off-Label Use	2	2
Self-Activation or Keying	2	2
Material Separation	2	2
Defective Component	2	2
Structural Problem	2	2
Failure to Disconnect	2	2
Arcing	1	1
Low Battery	1	1
Defective Device	1	1
Inadequate Storage	1	1
Device Markings/Labelling Problem	1	1
Extrusion	1	1
Failure to Auto Stop	1	1
Failure to Shut Off	1	1
Gas/Air Leak	1	1
Human-Device Interface Problem	1	1
Out-Of-Box Failure	1	1
Cut In Material	1	1
Computer Operating System Problem	1	1
Malposition of Device	1	1
No Device Output	1	1
Peeled/Delaminated	1	1
Difficult To Position	1	1
Failure to Power Up	1	1
Fracture	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Misassembled	1	1
Device Emits Odor	1	1
Disconnection	1	1
Material Disintegration	1	1
Corroded	1	1
Device Alarm System	1	1
Alarm Not Visible	1	1
Premature Discharge of Battery	1	1
Moisture or Humidity Problem	1	1
No Fail-Safe Mechanism	1	1
Material Deformation	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Scratched Material	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	494	494
No Known Impact Or Consequence To Patient	133	133
No Code Available	76	76
Fall	75	75
Injury	61	61
Bone Fracture(s)	57	57
Bruise/Contusion	49	49
No Information	47	47
Abrasion	33	33
No Clinical Signs, Symptoms or Conditions	29	29
Hip Fracture	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Laceration(s)	11	11
Death	10	10
Head Injury	9	9
Pain	8	8
Contusion	6	6
Fracture, Arm	5	5
Skin Tears	5	5
Neck Pain	4	4
Damage to Ligament(s)	4	4
Complaint, Ill-Defined	3	3
Concussion	3	3
Limb Fracture	3	3
Muscle/Tendon Damage	3	3
Insufficient Information	2	2
Discomfort	2	2
No Patient Involvement	2	2
Joint Dislocation	2	2
Tooth Fracture	1	1
Suture Abrasion	1	1
Electric Shock	1	1
Deformity/ Disfigurement	1	1
Nerve Damage	1	1
Crushing Injury	1	1
Seizures	1	1
Sprain	1	1
Swelling	1	1
Pyrosis/Heartburn	1	1
Unspecified Infection	1	1
Aspiration/Inhalation	1	1
Cellulitis	1	1
Easy Bruising	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Electric Mobility Corp	II	Nov-18-2010
2	Golden Technologies, Inc.	II	Mar-20-2014
3	Invacare Corporation	II	Jan-17-2012
4	Merits Holdings Co. dba Merits Health Products, Inc.	II	Apr-28-2021
5	Pride Mobility Products Corp	II	Jul-03-2012
6	Pride Mobility Products Corp	II	Sep-14-2011
7	S.A.E. AFIKIM	II	Oct-30-2013