TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ANHUI JBH MEDICAL APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
DONGGUAN SMARFODY MOBILITY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
HEARTWAY MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTRADIN (SHANGHAI) MACHINERY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
JIANGSU BANGBANG INTELLIGENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI JIANGTE ELECTRIC VEHICLE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LERADO ZHONGSHAN PEACEFUL COVE BUSINESS TRADING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LICHTMEGA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOVING LIFE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING KANGNI SMART TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NANJING MIJO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO BAICHEN MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PUC PERFECT UNION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ZHIMAHUAERKAI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNTECH UK , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	3
SUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
TAIZHOU REACH TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
W'U'S TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WHILL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WU’S TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUYI AICHI INDUSTRY & TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUYI AICHI INDUSTRY AND TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YONGKANG YILE VEHICLE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
YUROB REHABILITATION MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
	SUBSTANTIALLY EQUIVALENT	9
ZHEJIANG NYSIN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG SEEDREAM MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG TAOTAO VEHICLE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG WEI LING NEW ENERGY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	41	41
2022	41	43
2023	32	33
2024	31	31
2025	27	27
2026	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	147	148
Fire	6	6
Insufficient Information	5	5
Unintended Movement	4	4
Detachment of Device or Device Component	4	4
Patient Device Interaction Problem	3	3
Break	2	2
Mechanical Problem	2	2
Off-Label Use	2	2
No Fail-Safe Mechanism	2	2
Structural Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Computer Software Problem	2	4
Human-Device Interface Problem	2	2
Device Slipped	1	1
Device Tipped Over	1	1
Failure to Auto Stop	1	1
Smoking	1	1
Battery Problem	1	1
Use of Device Problem	1	1
Device Unsafe to Use in Environment	1	1
Material Deformation	1	1
Device Dislodged or Dislocated	1	1
Protective Measures Problem	1	1
Unintended Collision	1	1
Temperature Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bruise/Contusion	51	51
No Clinical Signs, Symptoms or Conditions	38	39
Bone Fracture(s)	38	38
Abrasion	17	17
Fall	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Damage to Ligament(s)	9	9
Laceration(s)	8	8
Insufficient Information	3	4
Limb Fracture	3	3
Hip Fracture	2	2
Burn(s)	2	3
Pain	2	2
Physical Entrapment	2	2
Hemorrhage/Bleeding	2	2
Aspiration/Inhalation	1	1
Head Injury	1	1
Easy Bruising	1	1
Cellulitis	1	1
Neck Pain	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1

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