TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ANHUI JBH MEDICAL APPARATUS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
CHIEN TI ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
EUROGREEN INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HEARTWAY MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTRADIN (SHANGHAI) MACHINERY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MOVING LIFE LTD
	SUBSTANTIALLY EQUIVALENT	1
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
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
TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
WU'S TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
	SUBSTANTIALLY EQUIVALENT	6
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	25	25
2020	26	26
2021	41	41
2022	41	41
2023	32	32
2024	22	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	142	142
Fire	8	8
Insufficient Information	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Unintended Movement	4	4
Detachment of Device or Device Component	4	4
Device Tipped Over	3	3
Patient Device Interaction Problem	3	3
Mechanical Problem	2	2
Off-Label Use	2	2
Break	2	2
Computer Software Problem	2	2
Device Slipped	1	1
Physical Resistance/Sticking	1	1
Material Integrity Problem	1	1
Smoking	1	1
Battery Problem	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Device Unsafe to Use in Environment	1	1
Material Deformation	1	1
Protective Measures Problem	1	1
Human-Device Interface Problem	1	1
Temperature Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bone Fracture(s)	38	38
Bruise/Contusion	36	36
No Clinical Signs, Symptoms or Conditions	30	30
Injury	17	17
Abrasion	16	16
Fall	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Laceration(s)	8	8
No Known Impact Or Consequence To Patient	6	6
Damage to Ligament(s)	4	4
Head Injury	3	3
Insufficient Information	3	3
Limb Fracture	3	3
Muscle/Tendon Damage	3	3
Fracture, Arm	2	2
Hip Fracture	2	2
Burn(s)	2	2
Neck Pain	2	2
Pain	2	2
No Information	1	1
Aspiration/Inhalation	1	1
Suture Abrasion	1	1
Easy Bruising	1	1
Cellulitis	1	1
Nerve Damage	1	1
Concussion	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Merits Holdings Co. dba Merits Health Products, Inc.	II	Apr-28-2021