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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 4
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
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
NANJING KANGNI SMART TECHNOLOGY 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 3
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 2
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 9
ZHEJIANG SEEDREAM MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG TAOTAO VEHICLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 26 26
2021 41 41
2022 41 43
2023 32 33
2024 31 31
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 160 161
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 4
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 51 51
Bone Fracture(s) 40 40
No Clinical Signs, Symptoms or Conditions 36 37
Abrasion 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Fall 12 12
Damage to Ligament(s) 8 8
Laceration(s) 8 8
Injury 5 5
Head Injury 3 3
Insufficient Information 3 4
Muscle/Tendon Damage 3 3
Limb Fracture 3 3
Hip Fracture 2 2
Neck Pain 2 2
Burn(s) 2 3
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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