Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device vehicle, motorized 3-wheeled
Product CodeINI
Regulation Number 890.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED VEHICLE CONCEPTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
AFIKIM ELECTRIC VEHICLES
  SUBSTANTIALLY EQUIVALENT 1
AGILE DISTRIBUTORS LLC
  SUBSTANTIALLY EQUIVALENT 1
AMIGO MOBILITY INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI JBH MEDICAL APPARATUS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BESTEAM TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
C.T.M. HOMECARE PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 4
CHIEN TI ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DONGGUAN PRESTIGE SPORTING GOODS., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EUROGREEN INTERNATIONAL INC
  SUBSTANTIALLY EQUIVALENT 1
EUROGREEN INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
FREERIDER CORP
  SUBSTANTIALLY EQUIVALENT 1
FREERIDER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FREERIDER LUGGIE SCOOTERS INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG PRESTIGE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HEARTWAY MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
INTRADIN (SHANGHAI) MACHINERY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KWANG YANG MOTOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LETRIX POWER HANGZHOU PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
MERITS HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MOVING LIFE LTD
  SUBSTANTIALLY EQUIVALENT 2
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PRESTIGE SPORTING GOODS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 4
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
SVRC INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN KEPLER VEHICLE INDUSTRY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TZORA ACTIVE SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 3
WU'S TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 567 567
2015 151 151
2016 76 76
2017 45 45
2018 51 51
2019 25 25
2020 26 26
2021 41 41
2022 41 41
2023 32 32
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 254 254
Break 112 112
Device Stops Intermittently 88 88
Device Operates Differently Than Expected 74 74
Product Quality Problem 71 71
Unintended Movement 67 67
Device Inoperable 58 58
Unstable 43 43
Device Tipped Over 38 38
Fire 35 35
Adverse Event Without Identified Device or Use Problem 35 35
Battery Problem 25 25
Loss of Power 18 18
Detachment Of Device Component 17 17
Mechanical Problem 17 17
Crack 15 15
Insufficient Information 14 14
Component Falling 12 12
Unintended Collision 10 10
Unintended System Motion 9 9
Device Displays Incorrect Message 8 8
Naturally Worn 7 7
Sparking 7 7
Thermal Decomposition of Device 7 7
Charging Problem 6 6
Noise, Audible 6 6
Overheating of Device 6 6
Electronic Property Issue 6 6
Bent 6 6
Use of Device Problem 5 5
Torn Material 5 5
Melted 5 5
Device Slipped 5 5
Detachment of Device or Device Component 5 5
Improper or Incorrect Procedure or Method 4 4
Sticking 4 4
Mechanical Jam 4 4
Fluid/Blood Leak 3 3
Component Missing 3 3
Burst Container or Vessel 3 3
Temperature Problem 3 3
Electrical /Electronic Property Problem 3 3
Patient Device Interaction Problem 3 3
Environmental Compatibility Problem 3 3
Device Damaged Prior to Use 3 3
Smoking 3 3
Electrical Shorting 2 2
No Apparent Adverse Event 2 2
Material Separation 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 494 494
No Known Impact Or Consequence To Patient 133 133
No Code Available 76 76
Fall 75 75
Injury 61 61
Bone Fracture(s) 59 59
Bruise/Contusion 55 55
No Information 47 47
Abrasion 34 34
No Clinical Signs, Symptoms or Conditions 30 30
Hip Fracture 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Laceration(s) 13 13
Death 10 10
Head Injury 9 9
Pain 8 8
Contusion 6 6
Damage to Ligament(s) 6 6
Skin Tears 5 5
Fracture, Arm 5 5
Neck Pain 4 4
Concussion 3 3
Insufficient Information 3 3
Complaint, Ill-Defined 3 3
Limb Fracture 3 3
Muscle/Tendon Damage 3 3
Burn(s) 2 2
Discomfort 2 2
No Patient Involvement 2 2
Joint Dislocation 2 2
Aspiration/Inhalation 1 1
Crushing Injury 1 1
Pyrosis/Heartburn 1 1
Tooth Fracture 1 1
Suture Abrasion 1 1
Easy Bruising 1 1
Sprain 1 1
Seizures 1 1
Cellulitis 1 1
Electric Shock 1 1
Nerve Damage 1 1
Swelling 1 1
Unspecified Infection 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Electric Mobility Corp II Nov-18-2010
2 Golden Technologies, Inc. II Mar-20-2014
3 Invacare Corporation II Jan-17-2012
4 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-28-2021
5 Pride Mobility Products Corp II Jul-03-2012
6 Pride Mobility Products Corp II Sep-14-2011
7 S.A.E. AFIKIM II Oct-30-2013
-
-