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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wheelchair, mechanical
Regulation Description Mechanical wheelchair.
Definition A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.
Product CodeIOR
Regulation Number 890.3850
Device Class 1


Premarket Reviews
ManufacturerDecision
ANHUI JBH MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI LONGWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOWHEAD DESIGN CORP.
  SUBSTANTIALLY EQUIVALENT 1
EMPOWER RIDE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN NANHAI HONGCHEN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN SHUNKANGDA MEDICAL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FREE WHEELCHAIR MISSION
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG DAYANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG YONG YI REHABILITATION EQUIPMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI RUILANGDE MEDICAL EQUIPMENT TECHNOLOGY GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., , LTD.
  SUBSTANTIALLY EQUIVALENT 3
KARMA MOBILITY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KI MOBILITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
LICHTMEGA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOBILITY SOURCE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOTION COMPOSITES
  SUBSTANTIALLY EQUIVALENT 1
NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
PANTHERA AB
  SUBSTANTIALLY EQUIVALENT 1
POWER PLUS MOBILITY
  SUBSTANTIALLY EQUIVALENT 1
REHASENSE USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROUGHRIDER AMERICA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SICHUAN AST MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
TURBO WHEELCHAIR CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2021 59 59
2022 37 40
2023 165 165
2024 138 138
2025 138 138
2026 3060 3076

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 1032 1047
Material Twisted/Bent 460 461
Detachment of Device or Device Component 444 444
Activation Problem 331 331
Mechanical Problem 249 249
Break 248 248
Loose or Intermittent Connection 117 117
Mechanical Jam 109 109
Unstable 100 100
Crack 79 79
Material Separation 76 76
Insufficient Device Problem Information 49 49
Appropriate Device Problem Term/Code Not Available 42 42
Component Missing 40 40
Damaged Thread 38 38
Activation Failure 37 37
Material Split, Cut or Torn 35 35
No Apparent Adverse Event 34 34
Material Integrity Problem 28 28
Use of Device Problem 23 23
Mechanics Altered 23 23
Unintended Movement 22 22
Loss of or Failure to Bond 21 21
Adverse Event Without Identified Device or Use Problem 20 20
Failure to Align 19 19
Physical Resistance/Sticking 18 18
Sharp Edges 18 18
Difficult to Fold, Unfold or Collapse 17 17
Defective Component 16 16
Separation Problem 14 14
Peeled/Delaminated 14 14
Incomplete or Inadequate Connection 13 13
Structural Problem 11 11
Difficult to Open or Close 10 10
Naturally Worn 10 10
Material Deformation 7 7
Human-Device Interface Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Solder Joint Fracture 6 6
Material Fragmentation 6 6
Noise, Audible 6 6
Misassembly by Users 5 5
Premature Separation 5 5
Activation, Positioning or Separation Problem 5 5
Device Slipped 5 5
Separation Failure 4 4
Corroded 4 4
Incomplete or Missing Packaging 4 4
Positioning Failure 4 4
Dent in Material 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3188 3206
Fall 111 111
Insufficient Information 101 102
Bone Fracture(s) 63 63
Laceration(s) 46 46
Bruise/Contusion 20 20
Pain 17 17
Limb Fracture 16 16
Abrasion 13 13
Head Injury 12 12
Hip Fracture 9 9
Swelling/ Edema 9 9
Concussion 6 6
Limb Pain 6 6
Skin Tears 6 6
Discomfort 5 5
Hematoma 5 5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Unspecified Musculoskeletal problem 4 4
Multiple Fractures 4 4
Loss of consciousness 4 4
Unspecified Tissue Injury 4 4
Ambulation or Postural Difficulties 3 3
Strangulation 3 3
Back pain 3 3
Convulsion/Seizure 3 3
Crushing Injury 3 3
Brain Injury 3 3
Neck Stiffness 2 2
Burn(s) 2 2
Easy Bruising 2 2
Muscle/Tendon Damage 2 2
Dementia 2 2
Hyperextension 2 2
Pressure Sore/Ulcer 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Damage to Ligament(s) 2 2
Shaking/Tremors 1 1
Anxiety 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Eye Injury 1 1
Abscess 1 1
Headache 1 1
Inadequate Pain Relief 1 1
Nervous System Injury 1 1
Full thickness (Third Degree) Burn 1 1
Facial Paralysis 1 1
Loss of Range of Motion 1 1
Nerve Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 TiSport, Llc II Nov-18-2021
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