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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
Product CodeINI
Regulation Number 890.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
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 2
HEARTWAY MEDICAL PRODUCTS 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

MDR Year MDR Reports MDR Events
2019 25 25
2020 26 26
2021 41 41
2022 41 41
2023 32 32
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 132 132
Fire 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Insufficient Information 5 5
Detachment of Device or Device Component 4 4
Unintended Movement 4 4
Patient Device Interaction Problem 3 3
Device Tipped Over 3 3
Off-Label Use 2 2
Mechanical Problem 2 2
Break 2 2
Computer Software Problem 2 2
Device Unsafe to Use in Environment 1 1
Noise, Audible 1 1
Device Slipped 1 1
Temperature Problem 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Structural Problem 1 1
Use of Device Problem 1 1
Smoking 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 36 36
Bruise/Contusion 31 31
No Clinical Signs, Symptoms or Conditions 30 30
Injury 17 17
Fall 16 16
Abrasion 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Laceration(s) 6 6
No Known Impact Or Consequence To Patient 6 6
Damage to Ligament(s) 3 3
Head Injury 3 3
Limb Fracture 3 3
Muscle/Tendon Damage 3 3
Insufficient Information 2 2
Burn(s) 2 2
Pain 2 2
Hip Fracture 2 2
Fracture, Arm 2 2
Neck Pain 2 2
Suture Abrasion 1 1
Concussion 1 1
No Information 1 1
Cellulitis 1 1
Aspiration/Inhalation 1 1
Nerve Damage 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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