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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
HEARTWAY MEDICAL PRODUCTS CO., 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
TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TZORA ACTIVE SYSTEMS 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 4

MDR Year MDR Reports MDR Events
2018 51 51
2019 25 25
2020 26 26
2021 41 41
2022 42 42
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 134 134
Fire 14 14
Adverse Event Without Identified Device or Use Problem 12 12
Device Tipped Over 7 7
Unintended Movement 6 6
Insufficient Information 5 5
Patient Device Interaction Problem 3 3
Break 3 3
Computer Software Problem 2 2
Use of Device Problem 2 2
Device Unsafe to Use in Environment 2 2
Failure to Auto Stop 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1
Device Damaged Prior to Use 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Off-Label Use 1 1
Self-Activation or Keying 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Physical Resistance/Sticking 1 1
Noise, Audible 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bruise/Contusion 32 32
Bone Fracture(s) 30 30
Injury 29 29
Fall 23 23
Abrasion 23 23
No Clinical Signs, Symptoms or Conditions 22 22
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
Concussion 3 3
Head Injury 3 3
No Information 3 3
Limb Fracture 3 3
Muscle/Tendon Damage 3 3
Damage to Ligament(s) 2 2
Death 2 2
No Consequences Or Impact To Patient 2 2
Pain 2 2
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
Insufficient Information 1 1
No Code Available 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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