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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
AAT ALBER ANTRIEBSTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
ACTION MANUFACTURING INC.
  SUBSTANTIALLY EQUIVALENT 1
ALBER GMBH
  SUBSTANTIALLY EQUIVALENT 5
AMIGO MOBILITY INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
AMYLIOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI JBH MEDICAL APPARATUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DALTON INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ELECTRIC MOBILITY CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELECTRO KINETIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EUROGREEN INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
FOSHAN DAHAO MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
FREEDOM SCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
FREERIDER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN MOTOR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEARTWAY MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HOVEROUND CORP.
  SUBSTANTIALLY EQUIVALENT 5
INVACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
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 AOSHIDA ELECTRIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LANZHOU WANLI AVIATION ELECTROMECHANICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LEVO AG
  SUBSTANTIALLY EQUIVALENT 1
LIL CRITTER, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAGIC MOBILITY
  SUBSTANTIALLY EQUIVALENT 4
MAX MOBILITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
MERITS HEALTH PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
METHOD MOBILITY
  SUBSTANTIALLY EQUIVALENT 1
MOTION CONCEPTS
  SUBSTANTIALLY EQUIVALENT 2
NANJING JIN BAI HE MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO BAICHEN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTH CARE, LP
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, LP
  SUBSTANTIALLY EQUIVALENT 1
PERMOBIL AB
  SUBSTANTIALLY EQUIVALENT 4
PIHSIANG MACHINERY MFG. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PRIDE MOBILITY PRODUCT CORPORRATION
  SUBSTANTIALLY EQUIVALENT 2
PRIDE MOBILITY PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SILVER FOX CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOLAR MOBILITYLLC
  SUBSTANTIALLY EQUIVALENT 1
SPINERGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL (US) LLC
  SUBSTANTIALLY EQUIVALENT 3
SUZHOU KD MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TUNG KENG ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VELOX MANUFACTURING INC
  SUBSTANTIALLY EQUIVALENT 1
VESTIL MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
WALK ON WHEELS AUSTRALIA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
WHILL, INC.
  SUBSTANTIALLY EQUIVALENT 3
WU'S TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YAMAHA MOTOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
2014 7282 7282
2015 4685 4685
2016 1575 1575
2017 301 301
2018 273 273
2019 264 264
2020 205 205
2021 166 166
2022 135 135
2023 224 224
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2530 2530
Break 2169 2169
Mechanical Problem 1239 1239
Leak/Splash 784 784
Appropriate Term/Code Not Available 649 649
Bent 632 632
Loss of Power 545 545
Device Displays Incorrect Message 541 541
Device Inoperable 539 539
Unintended Movement 529 529
Device Stops Intermittently 517 517
Device Slipped 516 516
Sticking 486 486
Detachment Of Device Component 415 415
Nonstandard Device 386 386
Failure to Shut Off 383 383
Unintended System Motion 311 311
Noise, Audible 292 292
Naturally Worn 282 282
Crack 265 265
Unintended Collision 261 261
Self-Activation or Keying 242 242
Mechanics Altered 208 208
Adverse Event Without Identified Device or Use Problem 207 207
Loose or Intermittent Connection 189 189
Failure to Power Up 183 183
Component Missing 180 180
Improper or Incorrect Procedure or Method 174 174
Use of Device Problem 172 172
Component Falling 163 163
Application Interface Becomes Non-Functional Or Program Exits Abnormally 151 151
Smoking 133 133
Insufficient Information 127 127
Electrical /Electronic Property Problem 122 122
Fire 122 122
Battery Problem 120 120
Overheating of Device 112 112
Unstable 107 107
Malposition of Device 105 105
Detachment of Device or Device Component 104 104
Fluid/Blood Leak 104 104
Material Integrity Problem 95 95
Device Tipped Over 94 94
Melted 90 90
Fracture 78 78
Positioning Problem 77 77
Mechanical Jam 76 76
Failure to Align 73 73
Device Emits Odor 69 69
Device Remains Activated 68 68
Torn Material 66 66
Sparking 65 65
No Device Output 63 63
No Display/Image 59 59
Electrical Shorting 56 56
Charging Problem 54 54
Thermal Decomposition of Device 53 53
Defective Component 49 49
Material Frayed 48 48
Defective Device 48 48
Out-Of-Box Failure 43 43
Cut In Material 40 40
Intermittent Continuity 40 40
Failure to Charge 39 39
Material Separation 39 39
Material Deformation 39 39
Connection Problem 36 36
Split 34 34
Power Problem 33 33
Programming Issue 32 32
Difficult or Delayed Activation 29 29
Circuit Failure 26 26
Corroded 26 26
Entrapment of Device 25 25
Temperature Problem 24 24
Material Protrusion/Extrusion 24 24
Material Twisted/Bent 23 23
Device Dislodged or Dislocated 23 23
Premature Discharge of Battery 23 23
Moisture Damage 22 22
Vibration 20 20
Chemical Spillage 20 20
Communication or Transmission Problem 20 20
Calibration Problem 19 19
Device Alarm System 19 19
Migration or Expulsion of Device 19 19
Peeled/Delaminated 18 18
Burst Container or Vessel 16 16
Scratched Material 16 16
Human-Device Interface Problem 15 15
Disconnection 15 15
Degraded 13 13
Arcing 13 13
Failure to Calibrate 13 13
No Apparent Adverse Event 13 13
Device Fell 13 13
Power Conditioning Problem 12 12
Material Disintegration 12 12
Hole In Material 12 12
Misassembled 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9649 9649
No Information 2796 2796
Injury 474 474
Fall 471 471
Bone Fracture(s) 462 462
No Consequences Or Impact To Patient 319 319
Bruise/Contusion 258 258
No Code Available 194 194
No Clinical Signs, Symptoms or Conditions 154 154
Laceration(s) 127 127
Abrasion 100 100
Death 67 67
Pain 51 51
Head Injury 47 47
Limb Fracture 47 47
Complaint, Ill-Defined 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Pressure Sores 37 37
Insufficient Information 36 36
Physical Entrapment 35 35
Concussion 28 28
Hip Fracture 26 26
Swelling 21 21
Contusion 20 20
No Patient Involvement 19 19
Multiple Fractures 17 17
Fracture, Arm 17 17
Hemorrhage/Bleeding 16 16
Discomfort 16 16
Unspecified Infection 15 15
Burn(s) 15 15
Sprain 15 15
Tissue Damage 12 12
Damage to Ligament(s) 11 11
Skin Tears 11 11
Joint Dislocation 9 9
Tooth Fracture 9 9
Skin Irritation 9 9
Hematoma 8 8
Brain Injury 8 8
Suture Abrasion 8 8
Neck Pain 7 7
Loss of consciousness 7 7
Electric Shock 7 7
Headache 7 7
Eye Injury 7 7
Erythema 6 6
Patient Problem/Medical Problem 6 6
Unspecified Tissue Injury 6 6
Swelling/ Edema 6 6
Vertebral Fracture 5 5
Tissue Breakdown 5 5
Inflammation 5 5
Skin Discoloration 5 5
Shock 4 4
Vertigo 4 4
Irritation 4 4
Muscle/Tendon Damage 4 4
Full thickness (Third Degree) Burn 4 4
Easy Bruising 3 3
Confusion/ Disorientation 3 3
Burn, Thermal 3 3
Spinal Cord Injury 3 3
Numbness 3 3
Crushing Injury 3 3
Cellulitis 3 3
Rash 3 3
Anxiety 3 3
Ulcer 2 2
Rupture 2 2
Seizures 2 2
Sepsis 2 2
Skull Fracture 2 2
Wound Dehiscence 2 2
Emotional Changes 2 2
Depression 2 2
Shaking/Tremors 2 2
Neck Stiffness 2 2
Ambulation Difficulties 2 2
Superficial (First Degree) Burn 2 2
Test Result 2 2
Not Applicable 1 1
Cancer 1 1
Unspecified Eye / Vision Problem 1 1
Retroperitoneal Hemorrhage 1 1
Unspecified Musculoskeletal problem 1 1
Blister 1 1
Subluxation 1 1
Caustic/Chemical Burns 1 1
Cognitive Changes 1 1
Hematuria 1 1
Alteration In Body Temperature 1 1
No Patient involvement 1 1
Bowel Perforation 1 1
Nervous System Injury 1 1
Partial thickness (Second Degree) Burn 1 1
Post Traumatic Wound Infection 1 1
Quadriplegia 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Invacare Corporation II May-25-2022
2 Invacare Corporation II Jan-03-2022
3 Invacare Corporation II Aug-10-2015
4 Invacare Corporation II Feb-20-2015
5 Invacare Corporation II Jul-22-2014
6 Invacare Corporation II Sep-23-2013
7 Invacare Corporation II Jun-29-2012
8 Invacare Corporation II Mar-12-2012
9 Invacare Corporation II Dec-29-2009
10 Invacare Corporation II Jan-27-2009
11 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-28-2021
12 Motion Concepts II Sep-17-2014
13 Permobil II Jun-26-2023
14 Permobil, Ab II Sep-15-2018
15 Permobil, Ab II Oct-03-2017
16 Pride Mobility Products Corp II Jan-03-2017
17 Pride Mobility Products Corp II Sep-29-2010
18 Sunrise Medical (US) LLC II May-11-2020
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