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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wheelchair, powered
Product CodeITI
Regulation Number 890.3860
Device Class 2


Premarket Reviews
ManufacturerDecision
21ST CENTURY SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALBER GMBH
  SUBSTANTIALLY EQUIVALENT 3
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 3
FOSHAN DAHAO MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN MOTOR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
KARMA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KI MOBILITY LLC
  SUBSTANTIALLY EQUIVALENT 1
KLAXON MOBILITY GMBH
  SUBSTANTIALLY EQUIVALENT 1
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MAGIC MOBILITY
  SUBSTANTIALLY EQUIVALENT 4
MERITS HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
METHOD MOBILITY
  SUBSTANTIALLY EQUIVALENT 1
MOTION CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
NINGBO BAICHEN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SILVER FOX CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL (US) LLC
  SUBSTANTIALLY EQUIVALENT 1
TUNG KENG ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VELOX MANUFACTURING INC
  SUBSTANTIALLY EQUIVALENT 1
WHILL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WU'S TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YAMAHA MOTOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG DINGCHANG INDUSTRY & TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG YOUHA ELECTRIC APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
YUROB REHABILITATION MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ZHEJIANG QIANXI VEHICLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 264 264
2020 205 205
2021 166 166
2022 135 135
2023 224 224
2024 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 368 368
Use of Device Problem 132 132
Mechanical Problem 99 99
Adverse Event Without Identified Device or Use Problem 90 90
Unintended Movement 73 73
Electrical /Electronic Property Problem 55 55
Break 54 54
Insufficient Information 45 45
Failure to Shut Off 43 43
Device Remains Activated 42 42
Detachment of Device or Device Component 36 36
Unintended Collision 27 27
Fire 22 22
Device Tipped Over 17 17
Noise, Audible 14 14
Unintended System Motion 13 13
Improper or Incorrect Procedure or Method 12 12
No Apparent Adverse Event 12 12
Device Fell 11 11
Material Integrity Problem 11 11
Fracture 10 10
Unstable 9 9
Unexpected Shutdown 9 9
Mechanical Jam 8 8
Component Missing 8 8
Battery Problem 7 7
Power Problem 7 7
Self-Activation or Keying 7 7
Misassembled 6 6
Patient Device Interaction Problem 6 6
Activation, Positioning or Separation Problem 5 5
Physical Resistance/Sticking 4 4
Sharp Edges 4 4
Activation Problem 4 4
Misassembly During Maintenance/Repair 4 4
Material Twisted/Bent 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Structural Problem 4 4
Defective Component 3 3
Material Deformation 3 3
Off-Label Use 3 3
Material Separation 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 3 3
Loose or Intermittent Connection 3 3
Intermittent Loss of Power 3 3
Device Difficult to Maintain 3 3
Device Handling Problem 3 3
Misassembled During Installation 2 2
Complete Loss of Power 2 2
Material Too Soft/Flexible 2 2
Material Split, Cut or Torn 2 2
Unintended Power Up 2 2
Failure to Charge 2 2
Circuit Failure 2 2
Collapse 2 2
Device Alarm System 2 2
Use of Incorrect Control/Treatment Settings 2 2
Smoking 2 2
Product Quality Problem 2 2
Overheating of Device 2 2
Device Emits Odor 2 2
Gas/Air Leak 2 2
Misassembly by Users 2 2
Output Problem 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Malposition of Device 1 1
Difficult or Delayed Activation 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Deformation Due to Compressive Stress 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Environmental Compatibility Problem 1 1
Fail-Safe Problem 1 1
Positioning Problem 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Temperature Problem 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Installation-Related Problem 1 1
Energy Output Problem 1 1
Accessory Incompatible 1 1
Material Puncture/Hole 1 1
Vibration 1 1
Positioning Failure 1 1
Premature Discharge of Battery 1 1
Component Incompatible 1 1
Display or Visual Feedback Problem 1 1
Unintended Ejection 1 1
Melted 1 1
Activation Failure 1 1
Wireless Communication Problem 1 1
Unintended Deflation 1 1
Key or Button Unresponsive/not Working 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 227 227
No Clinical Signs, Symptoms or Conditions 155 155
Injury 125 125
Fall 115 115
Bruise/Contusion 114 114
No Known Impact Or Consequence To Patient 80 80
Laceration(s) 67 67
Limb Fracture 48 48
Abrasion 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Insufficient Information 36 36
Pain 21 21
Head Injury 19 19
Concussion 17 17
Multiple Fractures 17 17
Pressure Sores 12 12
Death 12 12
No Consequences Or Impact To Patient 12 12
Damage to Ligament(s) 11 11
Hip Fracture 11 11
Burn(s) 10 10
Contusion 6 6
Tooth Fracture 6 6
Unspecified Tissue Injury 6 6
Swelling/ Edema 6 6
Vertebral Fracture 5 5
Neck Pain 5 5
Headache 5 5
Sprain 5 5
Swelling 4 4
Unspecified Infection 4 4
Skin Tears 4 4
Tissue Breakdown 4 4
Patient Problem/Medical Problem 4 4
Discomfort 4 4
Joint Dislocation 4 4
Physical Entrapment 4 4
Full thickness (Third Degree) Burn 4 4
Muscle/Tendon Damage 4 4
Suture Abrasion 3 3
Easy Bruising 3 3
Fracture, Arm 3 3
Eye Injury 3 3
Cellulitis 3 3
Crushing Injury 2 2
Hematoma 2 2
Inflammation 2 2
Skull Fracture 2 2
Vertigo 2 2
Rupture 2 2
Brain Injury 2 2
Depression 2 2
Numbness 2 2
Loss of consciousness 2 2
Spinal Cord Injury 2 2
No Information 2 2
Confusion/ Disorientation 2 2
Electric Shock 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
Ambulation Difficulties 1 1
Post Traumatic Wound Infection 1 1
Needle Stick/Puncture 1 1
No Code Available 1 1
Cancer 1 1
Unspecified Eye / Vision Problem 1 1
Retroperitoneal Hemorrhage 1 1
Nervous System Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Coma 1 1
Dizziness 1 1
Anxiety 1 1
Distress 1 1
Myalgia 1 1
Ulcer 1 1
Visual Impairment 1 1
Sepsis 1 1
Skin Discoloration 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Hearing Impairment 1 1
Dehydration 1 1
Embolus 1 1
Pulmonary Emphysema 1 1
Unspecified Musculoskeletal problem 1 1
Blister 1 1
Not Applicable 1 1
Subluxation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Invacare Corporation II May-25-2022
2 Invacare Corporation II Jan-03-2022
3 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-28-2021
4 Permobil II Jun-26-2023
5 Sunrise Medical (US) LLC II May-11-2020
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