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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
ACTION MANUFACTURING 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
EUROGREEN INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN DAHAO MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN MOTOR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARMA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KLAXON MOBILITY GMBH
  SUBSTANTIALLY EQUIVALENT 1
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MAGIC MOBILITY
  SUBSTANTIALLY EQUIVALENT 3
MERITS HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOTION CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILVER FOX CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL (US) LLC
  SUBSTANTIALLY EQUIVALENT 1
TUNG KENG ENTERPRISE CO., LTD.
  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
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG QIANXI VEHICLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 273 273
2019 264 264
2020 205 205
2021 166 166
2022 135 135
2023 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 382 382
Use of Device Problem 109 109
Adverse Event Without Identified Device or Use Problem 108 108
Unintended Movement 85 85
Break 84 84
Mechanical Problem 72 72
Detachment of Device or Device Component 54 54
Insufficient Information 41 41
Unintended Collision 37 37
Fire 31 31
Fracture 21 21
Improper or Incorrect Procedure or Method 17 17
Device Tipped Over 15 15
Device Fell 12 12
Material Integrity Problem 11 11
Electrical /Electronic Property Problem 11 11
Unintended System Motion 11 11
Unstable 10 10
No Apparent Adverse Event 9 9
Power Problem 8 8
Mechanical Jam 8 8
Self-Activation or Keying 7 7
Unexpected Shutdown 6 6
Patient Device Interaction Problem 5 5
Detachment Of Device Component 5 5
Activation, Positioning or Separation Problem 5 5
Structural Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Failure to Shut Off 4 4
Device Slipped 4 4
Smoking 4 4
Noise, Audible 4 4
Activation Problem 4 4
Misassembly During Maintenance/Repair 3 3
Sharp Edges 3 3
Intermittent Loss of Power 3 3
Misassembly by Users 3 3
Device Difficult to Maintain 3 3
Material Separation 3 3
Off-Label Use 3 3
Misassembled 3 3
Device Operates Differently Than Expected 3 3
Material Deformation 3 3
Material Twisted/Bent 3 3
Battery Problem 3 3
Loose or Intermittent Connection 3 3
Defective Component 3 3
Component Missing 2 2
Malposition of Device 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Output Problem 2 2
Device Operational Issue 2 2
Device Dislodged or Dislocated 2 2
Product Quality Problem 2 2
Device Remains Activated 2 2
Circuit Failure 2 2
Collapse 2 2
Device Alarm System 2 2
Use of Incorrect Control/Treatment Settings 2 2
Unintended Power Up 2 2
Disconnection 2 2
Device Handling Problem 2 2
Physical Resistance/Sticking 2 2
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Complete Loss of Power 1 1
Activation Failure 1 1
Temperature Problem 1 1
Misassembled During Installation 1 1
Display or Visual Feedback Problem 1 1
Positioning Failure 1 1
Unintended Ejection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Premature Discharge of Battery 1 1
Failure to Charge 1 1
Component Incompatible 1 1
Material Puncture/Hole 1 1
Device Emits Odor 1 1
Melted 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Loss of Power 1 1
Electrical Shorting 1 1
Environmental Compatibility Problem 1 1
Fail-Safe Problem 1 1
Gas/Air Leak 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Installation-Related Problem 1 1
Positioning Problem 1 1
Naturally Worn 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Charging Problem 1 1
Device Issue 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Vibration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 245 245
Injury 169 169
No Known Impact Or Consequence To Patient 148 148
Fall 109 109
Bruise/Contusion 96 96
No Clinical Signs, Symptoms or Conditions 70 70
Laceration(s) 64 64
Abrasion 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Limb Fracture 32 32
Death 26 26
Pain 22 22
No Consequences Or Impact To Patient 19 19
Head Injury 18 18
Insufficient Information 16 16
Concussion 15 15
Multiple Fractures 14 14
Pressure Sores 13 13
Hip Fracture 12 12
No Code Available 11 11
Fracture, Arm 9 9
No Information 9 9
Tooth Fracture 7 7
Sprain 7 7
Contusion 7 7
Unspecified Infection 6 6
Joint Dislocation 6 6
Neck Pain 5 5
Discomfort 5 5
Suture Abrasion 5 5
Patient Problem/Medical Problem 5 5
Damage to Ligament(s) 5 5
Swelling 5 5
Burn(s) 5 5
Vertebral Fracture 5 5
Unspecified Tissue Injury 5 5
Muscle/Tendon Damage 4 4
Skin Tears 4 4
Full thickness (Third Degree) Burn 4 4
Tissue Breakdown 3 3
Brain Injury 3 3
Cellulitis 3 3
Crushing Injury 3 3
Eye Injury 3 3
Hematoma 3 3
Easy Bruising 3 3
Swelling/ Edema 3 3
Skull Fracture 2 2
Sepsis 2 2
Rupture 2 2
Physical Entrapment 2 2
Headache 2 2
Depression 2 2
Spinal Cord Injury 2 2
Loss of consciousness 2 2
No Patient Involvement 2 2
Nervous System Injury 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 1 1
Electric Shock 1 1
Not Applicable 1 1
Partial thickness (Second Degree) Burn 1 1
Cancer 1 1
Unspecified Eye / Vision Problem 1 1
Retroperitoneal Hemorrhage 1 1
Coma 1 1
Needle Stick/Puncture 1 1
Non-union Bone Fracture 1 1
Myalgia 1 1
Ulcer 1 1
Complaint, Ill-Defined 1 1
Hearing Impairment 1 1
Wound Dehiscence 1 1
Dehydration 1 1
Embolus 1 1
Pulmonary Emphysema 1 1
Anxiety 1 1
Distress 1 1
Vertigo 1 1
Skin Discoloration 1 1
Inflammation 1 1
Unspecified Musculoskeletal problem 1 1
Blister 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, Ab II Sep-15-2018
5 Sunrise Medical (US) LLC II May-11-2020
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