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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wheelchair, powered
Regulation Description Powered wheelchair.
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
ANHUI LONGWAY MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BATEC MOBILITY, S.L.
  SUBSTANTIALLY EQUIVALENT 1
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
INTRADIN (SHANGHAI) MACHINERY 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
KLAXON-MOBILITY GMBH
  SUBSTANTIALLY EQUIVALENT 1
KUNSHAN HI-FORTUNE HEALTH PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
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 2
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
XSTO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
2025 133 133

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 348 348
Electrical /Electronic Property Problem 172 172
Device Remains Activated 160 160
Failure to Shut Off 160 160
Use of Device Problem 102 102
Mechanical Problem 97 97
Adverse Event Without Identified Device or Use Problem 67 67
Unintended Movement 58 58
Insufficient Information 41 41
Break 29 29
Detachment of Device or Device Component 21 21
Unintended Collision 20 20
Unintended System Motion 18 18
Device Tipped Over 15 15
Fire 14 14
Noise, Audible 13 13
Material Integrity Problem 11 11
No Apparent Adverse Event 11 11
Unstable 8 8
Component Missing 8 8
Unexpected Shutdown 8 8
Device Fell 8 8
Power Problem 8 8
Battery Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Misassembled 6 6
Mechanical Jam 6 6
Patient Device Interaction Problem 5 5
Fracture 5 5
Self-Activation or Keying 5 5
Activation, Positioning or Separation Problem 5 5
Complete Loss of Power 4 4
Activation Problem 4 4
Device Handling Problem 4 4
Structural Problem 4 4
Defective Component 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Physical Resistance/Sticking 3 3
Off-Label Use 3 3
Material Deformation 3 3
Material Split, Cut or Torn 3 3
Misassembly During Maintenance/Repair 3 3
Sharp Edges 3 3
Device Slipped 3 3
Device Difficult to Maintain 3 3
Material Too Soft/Flexible 2 2
Overheating of Device 2 2
Device Emits Odor 2 2
Misassembly by Users 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 282 282
Bone Fracture(s) 201 201
Bruise/Contusion 121 121
Fall 83 83
Laceration(s) 77 77
Limb Fracture 57 57
Injury 49 49
Insufficient Information 43 43
Abrasion 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Multiple Fractures 26 26
No Known Impact Or Consequence To Patient 25 25
Pain 21 21
Damage to Ligament(s) 19 19
Concussion 17 17
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 7 7
Vertebral Fracture 6 6
Unspecified Tissue Injury 6 6
Full thickness (Third Degree) Burn 5 5
Skin Tears 5 5
Tooth Fracture 5 5
Death 4 4
Joint Dislocation 4 4
Tissue Breakdown 4 4
Headache 4 4
Muscle/Tendon Damage 4 4
Physical Entrapment 4 4
Discomfort 3 3
Neck Pain 3 3
Unspecified Infection 3 3
Contusion 3 3
Cellulitis 3 3
Easy Bruising 3 3
Loss of consciousness 2 2
Brain Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Anxiety 2 2
Eye Injury 2 2
Inflammation 2 2
Crushing Injury 2 2
Numbness 2 2
Depression 2 2
Vertigo 2 2
Swelling 2 2
Confusion/ Disorientation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Invacare Corporation II May-25-2022
2 Invacare Corporation II Jan-03-2022
3 Max Mobility LLC I Feb-11-2025
4 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-28-2021
5 Permobil II Jun-26-2023
6 Sunrise Medical (US) LLC II May-11-2020
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