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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 2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN PRESTIGE SPORTING GOODS., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
TZORA ACTIVE SYSTEMS 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
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2018 51 51
2019 25 25
2020 26 26
2021 41 41
2022 41 41
2023 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 147 147
Fire 14 14
Adverse Event Without Identified Device or Use Problem 12 12
Device Tipped Over 8 8
Unintended Movement 6 6
Insufficient Information 5 5
Detachment of Device or Device Component 5 5
Break 3 3
Patient Device Interaction Problem 3 3
Use of Device Problem 2 2
Computer Software Problem 2 2
Mechanical Problem 2 2
Off-Label Use 2 2
Device Unsafe to Use in Environment 2 2
Failure to Auto Stop 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Device Damaged Prior to Use 1 1
Structural Problem 1 1
Battery Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Physical Resistance/Sticking 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 41 41
Bruise/Contusion 34 34
Injury 29 29
No Clinical Signs, Symptoms or Conditions 28 28
Fall 25 25
Abrasion 24 24
No Known Impact Or Consequence To Patient 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Laceration(s) 9 9
Hip Fracture 5 5
Fracture, Arm 4 4
Neck Pain 3 3
No Information 3 3
Pain 3 3
Concussion 3 3
Damage to Ligament(s) 3 3
Head Injury 3 3
Limb Fracture 3 3
Muscle/Tendon Damage 3 3
Insufficient Information 2 2
Death 2 2
No Consequences Or Impact To Patient 2 2
No Code Available 1 1
Suture Abrasion 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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