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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
ALBER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ANHUI JBH MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ANHUI LONGWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BATEC MOBILITY, S.L.
  SUBSTANTIALLY EQUIVALENT 1
CHANGSHU PINGFANG WHEELCHAIR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONCOURSE ASSISTIVE TECHNOLOGY PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FORCEMECH INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN DAHAO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GOLDEN MOTOR TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG PRESTIGE TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.
  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 1
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
JINHUA QIDIAN VEHICLE 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 8
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
NANJING KANGNI SMART TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO BAICHEN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROLLZ INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG GUYUE HEALTHCARE APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
SUNTECH UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUPERPI ROBOT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU IDEAL MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU KD INTELLIGENT DEVICE 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
VIVE HEALTH, LLC
  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
ZHE JIANG CLEISMAN INDUSTRY AND TRADE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG AUTOMWHEEL TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HFIZER MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD
  SUBSTANTIALLY EQUIVALENT 6
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 2
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 TOPWE TOOLS MANUFACTURING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG ZHONGLEI MEDICAL TECHNOLOGY CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 166 166
2022 135 136
2023 223 227
2024 146 146
2025 651 651

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 573 573
Failure to Shut Off 560 560
Device Remains Activated 558 558
Appropriate Term/Code Not Available 345 346
Mechanical Problem 92 92
Use of Device Problem 73 73
Adverse Event Without Identified Device or Use Problem 49 49
Unintended Movement 43 43
Insufficient Information 36 36
Break 20 20
Detachment of Device or Device Component 19 19
Unintended System Motion 18 18
Device Tipped Over 14 14
Noise, Audible 13 13
Unintended Collision 12 12
Fire 11 11
Self-Activation or Keying 11 11
Power Problem 11 15
Material Integrity Problem 11 11
No Apparent Adverse Event 9 9
Complete Loss of Power 8 8
Unstable 7 7
Component Missing 7 7
Battery Problem 7 11
Mechanical Jam 6 6
Improper or Incorrect Procedure or Method 6 6
Unexpected Shutdown 6 6
Patient Device Interaction Problem 6 6
Activation, Positioning or Separation Problem 5 5
Device Fell 5 5
Device Handling Problem 5 5
Fail-Safe Problem 4 4
Misassembled 4 4
Inadequacy of Device Shape and/or Size 4 4
Unintended Power Up 4 4
Activation Problem 4 4
Output Problem 4 4
Defective Component 3 7
Fracture 3 3
Material Deformation 3 3
Nonstandard Device 3 3
Sharp Edges 3 3
Material Split, Cut or Torn 3 3
Structural Problem 3 3
Device Difficult to Maintain 3 3
Product Quality Problem 2 2
Device Emits Odor 2 2
Misassembly by Users 2 2
Material Too Soft/Flexible 2 2
Misassembly During Maintenance/Repair 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 665 665
Bone Fracture(s) 181 181
Bruise/Contusion 144 145
Laceration(s) 77 77
Fall 74 74
Limb Fracture 54 54
Insufficient Information 51 51
Abrasion 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Multiple Fractures 25 25
Damage to Ligament(s) 21 21
Pain 18 18
Concussion 16 16
Head Injury 15 15
Burn(s) 14 14
Pressure Sores 10 10
Unspecified Tissue Injury 10 10
Hip Fracture 9 9
Swelling/ Edema 8 8
Vertebral Fracture 6 6
Muscle/Tendon Damage 5 5
Full thickness (Third Degree) Burn 5 5
Skin Tears 5 5
Physical Entrapment 4 4
Anxiety 4 4
Easy Bruising 4 4
Headache 4 4
Tissue Breakdown 4 4
Joint Dislocation 4 4
Neck Pain 3 3
Discomfort 3 3
Brain Injury 3 3
Distress 3 3
Partial thickness (Second Degree) Burn 2 2
Cellulitis 2 2
Confusion/ Disorientation 2 2
Rupture 2 2
Crushing Injury 2 2
Inflammation 2 2
Vertigo 2 2
Numbness 2 2
Skin Infection 2 2
Unspecified Infection 2 2
Unspecified Respiratory Problem 1 1
Ulcer 1 1
Hemorrhage/Bleeding 1 1
Subluxation 1 1
Heart Failure/Congestive Heart Failure 1 1
Eye Injury 1 1
Ambulation Difficulties 1 5

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 Sep-12-2025
4 Max Mobility LLC I Feb-11-2025
5 Merits Holdings Co. dba Merits Health Products, Inc. II Apr-28-2021
6 Permobil II Jun-26-2023
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