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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vehicle, motorized 3-wheeled
Regulation Description Motorized three-wheeled vehicle.
Product CodeINI
Regulation Number 890.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI JBH MEDICAL APPARATUS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HEARTWAY MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTRADIN (SHANGHAI) MACHINERY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
JIANGXI JIANGTE ELECTRIC VEHICLE 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
PUC PERFECT UNION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUNTECH UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MASTER MACHINERY MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SWEETRICH VEHICLE INDUSTRY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
WU’S TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUYI AICHI INDUSTRY & TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG YILE VEHICLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG YILE VEHICLE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 6
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG SEEDREAM MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 26 26
2021 41 41
2022 41 41
2023 32 32
2024 31 31
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 144 144
Fire 7 7
Insufficient Information 5 5
Adverse Event Without Identified Device or Use Problem 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
Device Tipped Over 2 2
Unintended Movement 2 2
Computer Software Problem 2 2
Device Slipped 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
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
Bruise/Contusion 41 41
Bone Fracture(s) 37 37
No Clinical Signs, Symptoms or Conditions 34 34
Abrasion 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Fall 12 12
Laceration(s) 8 8
Damage to Ligament(s) 7 7
Injury 5 5
Head Injury 3 3
Insufficient Information 3 3
Muscle/Tendon Damage 3 3
Limb Fracture 3 3
Hip Fracture 2 2
Neck Pain 2 2
Burn(s) 2 2
Pain 2 2
Fracture, Arm 1 1
Aspiration/Inhalation 1 1
Easy Bruising 1 1
No Known Impact Or Consequence To Patient 1 1
Cellulitis 1 1
Concussion 1 1
Swelling/ Edema 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
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