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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 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
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
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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 136 136
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
Computer Software Problem 2 2
Unintended Movement 2 2
Mechanical Problem 2 2
Off-Label Use 2 2
Break 2 2
Device Tipped Over 2 2
Material Deformation 1 1
Device Unsafe to Use in Environment 1 1
Human-Device Interface Problem 1 1
Noise, Audible 1 1
Battery Problem 1 1
Device Slipped 1 1
Protective Measures Problem 1 1
Use of Device Problem 1 1
Smoking 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bruise/Contusion 37 37
Bone Fracture(s) 36 36
No Clinical Signs, Symptoms or Conditions 33 33
Abrasion 19 19
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
Limb Fracture 3 3
Muscle/Tendon Damage 3 3
Insufficient Information 3 3
Hip Fracture 2 2
Neck Pain 2 2
Pain 2 2
Burn(s) 2 2
Fracture, Arm 1 1
No Known Impact Or Consequence To Patient 1 1
Concussion 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 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-28-2021
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