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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.
Definition A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).
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
BEIJING ORIONSTAR TECHNOLOGY CO., LTD.
  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 3
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
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 2
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU YVEELT 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 CAREMOVING REHABILITATION EQUIPMENT CO.,LTD
  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 SHENYU MEDICAL EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NINGBO ZHISHAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROLLZ INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG GUYUE HEALTHCARE APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHANGHAI HUBANG INTELLIGENT REHABILITATION EQUIPMENT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YATTLL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHIMAHUAERKAI TECHNOLOGY 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 2
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 2
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 2
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 8
ZHEJIANG J&J MOBILITY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 YIKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG ZHONGLEI MEDICAL TECHNOLOGY CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 166 166
2022 135 136
2023 223 227
2024 145 145
2025 651 651
2026 415 415

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 914 914
Failure to Shut Off 898 898
Device Remains Activated 896 896
Appropriate Term/Code Not Available 383 384
Mechanical Problem 95 95
Use of Device Problem 83 83
Adverse Event Without Identified Device or Use Problem 54 54
Unintended Movement 46 46
Insufficient Information 41 41
Break 21 21
Detachment of Device or Device Component 20 20
Unintended System Motion 19 19
Device Tipped Over 18 18
No Apparent Adverse Event 15 15
Unintended Collision 14 14
Self-Activation or Keying 14 14
Power Problem 14 18
Noise, Audible 13 13
Fire 12 12
Material Integrity Problem 11 11
Complete Loss of Power 10 10
Mechanical Jam 7 7
Improper or Incorrect Procedure or Method 7 7
Component Missing 7 7
Battery Problem 7 11
Unstable 7 7
Activation, Positioning or Separation Problem 6 6
Unexpected Shutdown 6 6
Patient Device Interaction Problem 6 6
Device Handling Problem 6 6
Device Fell 5 5
Defective Component 5 9
Activation Problem 5 5
Misassembled 5 5
Nonstandard Device 4 4
Output Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Unintended Power Up 4 4
Fail-Safe Problem 4 4
Material Split, Cut or Torn 3 3
Fracture 3 3
Physical Resistance/Sticking 3 3
Material Deformation 3 3
Device Difficult to Maintain 3 3
Sharp Edges 3 3
Structural Problem 3 3
Circuit Failure 2 2
Temperature Problem 2 2
Operating System Becomes Nonfunctional 2 2
Overheating of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1009 1009
Bone Fracture(s) 201 201
Bruise/Contusion 165 166
Laceration(s) 82 82
Fall 75 75
Limb Fracture 55 55
Insufficient Information 55 55
Abrasion 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Multiple Fractures 30 30
Damage to Ligament(s) 25 25
Pain 22 22
Concussion 19 19
Burn(s) 18 18
Head Injury 15 15
Unspecified Tissue Injury 11 11
Pressure Sores 11 11
Hip Fracture 9 9
Swelling/ Edema 8 8
Vertebral Fracture 8 8
Full thickness (Third Degree) Burn 7 7
Muscle/Tendon Damage 6 6
Skin Tears 5 5
Discomfort 5 5
Headache 4 4
Easy Bruising 4 4
Tissue Breakdown 4 4
Neck Pain 4 4
Anxiety 4 4
Joint Dislocation 4 4
Physical Entrapment 4 4
Brain Injury 3 3
Distress 3 3
Inflammation 2 2
Crushing Injury 2 2
Rupture 2 2
Multiple Organ Failure 2 2
Partial thickness (Second Degree) Burn 2 2
Cellulitis 2 2
Confusion/ Disorientation 2 2
Ulcer 2 2
Paralysis 2 2
Vertigo 2 2
Numbness 2 2
Skin Infection 2 2
Unspecified Infection 2 2
Hemorrhage/Bleeding 1 1
Unspecified Respiratory Problem 1 1
Subluxation 1 1
Heart Failure/Congestive Heart Failure 1 1

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
7 WHILL, INC. I Apr-24-2026
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