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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
ANHUI JBH MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
CONCOURSE ASSISTIVE TECHNOLOGY PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
FORCEMECH INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN DAHAO MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GOLDEN MOTOR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG PRESTIGE TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IF HEALTH (XIAMEN) INTELLIGENT 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
JIAXING XIAOXIANG MEDICAL EQUIPMENT TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KARMA MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KI MOBILITY LLC
  SUBSTANTIALLY EQUIVALENT 1
KLAXON MOBILITY GMBH
  SUBSTANTIALLY EQUIVALENT 2
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
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
NANJING E-TAKE MEDICAL APPARATUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO BAICHEN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI HUBANG INTELLIGENT REHABILITATION EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YATTLL INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SILVER FOX CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOUL MOBILITY
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL (US) LLC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU IDEAL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU MASTER MACHINERY MANUFACTURING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
TUNG KENG ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VELOX MANUFACTURING INC
  SUBSTANTIALLY EQUIVALENT 1
WHILL, INC.
  SUBSTANTIALLY EQUIVALENT 2
YAMAHA MOTOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG DINGCHANG INDUSTRY & TRADE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG HENGYI VEHICLE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
YONGKANG YOUHA ELECTRIC APPLIANCE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
YUROB REHABILITATION MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HFIZER MEDICAL EQUIPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG INNUOVO REHABILITATION DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
ZHEJIANG J&J MOBILITY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG JIANRUI TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KAIRUI MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG KAIRUI MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG NYSIN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG QIANXI VEHICLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG RICHALL MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG ZHONGLEI MEDICAL TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG ZHONGLEI MEDICAL TECHNOLOGY CO.LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 205 205
2021 166 166
2022 135 135
2023 223 223
2024 146 146

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 340 340
Use of Device Problem 101 101
Mechanical Problem 95 95
Electrical /Electronic Property Problem 64 64
Adverse Event Without Identified Device or Use Problem 63 63
Unintended Movement 57 57
Device Remains Activated 52 52
Failure to Shut Off 52 52
Insufficient Information 39 39
Break 29 29
Detachment of Device or Device Component 21 21
Unintended Collision 19 19
Unintended System Motion 17 17
Device Tipped Over 15 15
Fire 14 14
Noise, Audible 13 13
No Apparent Adverse Event 11 11
Material Integrity Problem 11 11
Unstable 8 8
Unexpected Shutdown 8 8
Component Missing 8 8
Device Fell 8 8
Improper or Incorrect Procedure or Method 7 7
Power Problem 7 7
Battery Problem 7 7
Mechanical Jam 6 6
Misassembled 6 6
Self-Activation or Keying 5 5
Fracture 5 5
Patient Device Interaction Problem 5 5
Activation, Positioning or Separation Problem 5 5
Activation Problem 4 4
Device Handling Problem 4 4
Structural Problem 4 4
Off-Label Use 3 3
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Physical Resistance/Sticking 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Deformation 3 3
Device Slipped 3 3
Misassembly During Maintenance/Repair 3 3
Sharp Edges 3 3
Device Difficult to Maintain 3 3
Complete Loss of Power 3 3
Material Split, Cut or Torn 3 3
Output Problem 2 2
Device Emits Odor 2 2
Misassembly by Users 2 2
Device Alarm System 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 195 195
No Clinical Signs, Symptoms or Conditions 177 177
Bruise/Contusion 115 115
Fall 81 81
Laceration(s) 70 70
Limb Fracture 55 55
Injury 49 49
Abrasion 40 40
Insufficient Information 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
No Known Impact Or Consequence To Patient 25 25
Multiple Fractures 24 24
Damage to Ligament(s) 18 18
Pain 18 18
Concussion 16 16
Head Injury 15 15
Pressure Sores 12 12
Burn(s) 12 12
Hip Fracture 11 11
No Consequences Or Impact To Patient 7 7
Swelling/ Edema 6 6
Unspecified Tissue Injury 6 6
Vertebral Fracture 5 5
Full thickness (Third Degree) Burn 5 5
Tooth Fracture 5 5
Death 4 4
Joint Dislocation 4 4
Tissue Breakdown 4 4
Headache 4 4
Skin Tears 4 4
Muscle/Tendon Damage 4 4
Physical Entrapment 3 3
Discomfort 3 3
Neck Pain 3 3
Contusion 3 3
Cellulitis 3 3
Unspecified Infection 3 3
Easy Bruising 3 3
Confusion/ Disorientation 2 2
Swelling 2 2
Vertigo 2 2
Depression 2 2
Numbness 2 2
Loss of consciousness 2 2
Crushing Injury 2 2
Inflammation 2 2
Brain Injury 2 2
Eye Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Ambulation Difficulties 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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