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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
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 3
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 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
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 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 164 164

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 422 422
Adverse Event Without Identified Device or Use Problem 115 115
Use of Device Problem 115 115
Mechanical Problem 100 100
Unintended Movement 92 92
Break 86 86
Detachment of Device or Device Component 55 55
Insufficient Information 49 49
Unintended Collision 39 39
Electrical /Electronic Property Problem 37 37
Fire 34 34
Failure to Shut Off 27 27
Device Remains Activated 25 25
Fracture 21 21
Improper or Incorrect Procedure or Method 19 19
Device Tipped Over 19 19
Noise, Audible 14 14
Device Fell 13 13
Unintended System Motion 13 13
Material Integrity Problem 11 11
No Apparent Adverse Event 10 10
Unstable 10 10
Power Problem 9 9
Mechanical Jam 8 8
Patient Device Interaction Problem 7 7
Unexpected Shutdown 7 7
Component Missing 7 7
Self-Activation or Keying 7 7
Battery Problem 6 6
Activation, Positioning or Separation Problem 5 5
Structural Problem 5 5
Smoking 5 5
Detachment Of Device Component 5 5
Loose or Intermittent Connection 4 4
Device Slipped 4 4
Defective Component 4 4
Activation Problem 4 4
Sharp Edges 4 4
Material Twisted/Bent 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Material Deformation 3 3
Misassembly by Users 3 3
Device Difficult to Maintain 3 3
Intermittent Loss of Power 3 3
Misassembly During Maintenance/Repair 3 3
Device Operates Differently Than Expected 3 3
Material Separation 3 3
Inadequacy of Device Shape and/or Size 3 3
Misassembled 3 3
Off-Label Use 3 3
Device Emits Odor 2 2
Device Alarm System 2 2
Failure to Charge 2 2
Circuit Failure 2 2
Collapse 2 2
Use of Incorrect Control/Treatment Settings 2 2
Positioning Failure 2 2
Unintended Power Up 2 2
Disconnection 2 2
Device Operational Issue 2 2
Device Dislodged or Dislocated 2 2
Malposition of Device 2 2
Fail-Safe Problem 2 2
Installation-Related Problem 2 2
Gas/Air Leak 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Product Quality Problem 2 2
Misassembled During Installation 2 2
Material Too Soft/Flexible 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Complete Loss of Power 2 2
Device Handling Problem 2 2
Output Problem 2 2
Positioning Problem 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Activation Failure 1 1
Temperature Problem 1 1
Wireless Communication Problem 1 1
Unintended Deflation 1 1
Key or Button Unresponsive/not Working 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Vibration 1 1
Sparking 1 1
Difficult or Delayed Activation 1 1
Device Issue 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Electrical Shorting 1 1
Environmental Compatibility Problem 1 1
Deformation Due to Compressive Stress 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1
Display or Visual Feedback Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 263 263
Injury 169 169
No Known Impact Or Consequence To Patient 148 148
No Clinical Signs, Symptoms or Conditions 130 130
Fall 120 120
Bruise/Contusion 111 111
Laceration(s) 71 71
Abrasion 62 62
Limb Fracture 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Insufficient Information 32 32
Death 26 26
Pain 22 22
No Consequences Or Impact To Patient 19 19
Head Injury 19 19
Concussion 17 17
Multiple Fractures 16 16
Hip Fracture 13 13
Pressure Sores 13 13
No Code Available 11 11
Fracture, Arm 9 9
Burn(s) 9 9
No Information 9 9
Contusion 7 7
Sprain 7 7
Damage to Ligament(s) 7 7
Tooth Fracture 7 7
Joint Dislocation 6 6
Unspecified Infection 6 6
Swelling 5 5
Discomfort 5 5
Neck Pain 5 5
Patient Problem/Medical Problem 5 5
Suture Abrasion 5 5
Skin Tears 5 5
Unspecified Tissue Injury 5 5
Vertebral Fracture 5 5
Full thickness (Third Degree) Burn 4 4
Muscle/Tendon Damage 4 4
Physical Entrapment 4 4
Tissue Breakdown 3 3
Vertigo 3 3
Brain Injury 3 3
Hematoma 3 3
Crushing Injury 3 3
Eye Injury 3 3
Headache 3 3
Cellulitis 3 3
Swelling/ Edema 3 3
Easy Bruising 3 3
Inflammation 2 2
Sepsis 2 2
Rupture 2 2
Skull Fracture 2 2
Loss of consciousness 2 2
No Patient Involvement 2 2
Confusion/ Disorientation 2 2
Depression 2 2
Spinal Cord Injury 2 2
Post Traumatic Wound Infection 1 1
Needle Stick/Puncture 1 1
Complaint, Ill-Defined 1 1
Coma 1 1
Non-union Bone Fracture 1 1
Anxiety 1 1
Distress 1 1
Electric Shock 1 1
Ambulation Difficulties 1 1
Bowel Perforation 1 1
Nervous System Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Cancer 1 1
Unspecified Eye / Vision Problem 1 1
Retroperitoneal Hemorrhage 1 1
Myalgia 1 1
Ulcer 1 1
Skin Discoloration 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Wound Dehiscence 1 1
Dehydration 1 1
Embolus 1 1
Pulmonary Emphysema 1 1
Hearing Impairment 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 Permobil, Ab II Sep-15-2018
6 Sunrise Medical (US) LLC II May-11-2020
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