Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
wheelchair, powered
Product Code
ITI
Regulation Number
890.3860
Device Class
2
Premarket Reviews
Manufacturer
Decision
21ST CENTURY SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
1
ACTION MANUFACTURING INC.
SUBSTANTIALLY EQUIVALENT
1
ALBER GMBH
SUBSTANTIALLY EQUIVALENT
3
ANHUI JBH MEDICAL APPARATUS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
SUBSTANTIALLY EQUIVALENT
2
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
EUROGREEN INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
2
FOSHAN DAHAO MEDICAL TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
GOLDEN MOTOR TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
INVACARE CORPORATION
SUBSTANTIALLY EQUIVALENT
3
JERRY MEDICAL INSTRUMENT (SHANGHAI) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
JIANGSU INTCO MEDICAL PRODUCTS 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 HI-FORTUNE HEALTH PRODUCTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
MAGIC MOBILITY
SUBSTANTIALLY EQUIVALENT
3
MERITS HEALTH PRODUCTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
METHOD MOBILITY
SUBSTANTIALLY EQUIVALENT
1
MOTION CONCEPTS
SUBSTANTIALLY EQUIVALENT
1
NINGBO BAICHEN MEDICAL DEVICES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI BANGBANG ROBOTICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SILVER FOX CORPORATION LIMITED
SUBSTANTIALLY EQUIVALENT
1
SUNRISE MEDICAL (US) LLC
SUBSTANTIALLY EQUIVALENT
1
TUNG KENG ENTERPRISE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
WHILL, INC.
SUBSTANTIALLY EQUIVALENT
2
WU'S TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
YAMAHA MOTOR CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
YONGKANG DINGCHANG INDUSTRY & TRADE 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
2
ZHEJIANG QIANXI VEHICLE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
273
273
2019
264
264
2020
205
205
2021
166
166
2022
135
135
2023
164
164
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
422
422
Adverse Event Without Identified Device or Use Problem
115
115
Use of Device Problem
115
115
Mechanical Problem
100
100
Unintended Movement
92
92
Break
86
86
Detachment of Device or Device Component
55
55
Insufficient Information
49
49
Unintended Collision
39
39
Electrical /Electronic Property Problem
37
37
Fire
34
34
Failure to Shut Off
27
27
Device Remains Activated
25
25
Fracture
21
21
Improper or Incorrect Procedure or Method
19
19
Device Tipped Over
19
19
Noise, Audible
14
14
Device Fell
13
13
Unintended System Motion
13
13
Material Integrity Problem
11
11
No Apparent Adverse Event
10
10
Unstable
10
10
Power Problem
9
9
Mechanical Jam
8
8
Patient Device Interaction Problem
7
7
Unexpected Shutdown
7
7
Component Missing
7
7
Self-Activation or Keying
7
7
Battery Problem
6
6
Activation, Positioning or Separation Problem
5
5
Structural Problem
5
5
Smoking
5
5
Detachment Of Device Component
5
5
Loose or Intermittent Connection
4
4
Device Slipped
4
4
Defective Component
4
4
Activation Problem
4
4
Sharp Edges
4
4
Material Twisted/Bent
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Material Deformation
3
3
Misassembly by Users
3
3
Device Difficult to Maintain
3
3
Intermittent Loss of Power
3
3
Misassembly During Maintenance/Repair
3
3
Device Operates Differently Than Expected
3
3
Material Separation
3
3
Inadequacy of Device Shape and/or Size
3
3
Misassembled
3
3
Off-Label Use
3
3
Device Emits Odor
2
2
Device Alarm System
2
2
Failure to Charge
2
2
Circuit Failure
2
2
Collapse
2
2
Use of Incorrect Control/Treatment Settings
2
2
Positioning Failure
2
2
Unintended Power Up
2
2
Disconnection
2
2
Device Operational Issue
2
2
Device Dislodged or Dislocated
2
2
Malposition of Device
2
2
Fail-Safe Problem
2
2
Installation-Related Problem
2
2
Gas/Air Leak
2
2
Defective Device
2
2
Device Displays Incorrect Message
2
2
Product Quality Problem
2
2
Misassembled During Installation
2
2
Material Too Soft/Flexible
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
2
2
Complete Loss of Power
2
2
Device Handling Problem
2
2
Output Problem
2
2
Positioning Problem
1
1
Mechanics Altered
1
1
Naturally Worn
1
1
Activation Failure
1
1
Temperature Problem
1
1
Wireless Communication Problem
1
1
Unintended Deflation
1
1
Key or Button Unresponsive/not Working
1
1
Material Perforation
1
1
Device Damaged Prior to Use
1
1
Vibration
1
1
Sparking
1
1
Difficult or Delayed Activation
1
1
Device Issue
1
1
Human Factors Issue
1
1
Human-Device Interface Problem
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Electrical Shorting
1
1
Environmental Compatibility Problem
1
1
Deformation Due to Compressive Stress
1
1
Charging Problem
1
1
Communication or Transmission Problem
1
1
Display or Visual Feedback Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Unintended Ejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Bone Fracture(s)
263
263
Injury
169
169
No Known Impact Or Consequence To Patient
148
148
No Clinical Signs, Symptoms or Conditions
130
130
Fall
120
120
Bruise/Contusion
111
111
Laceration(s)
71
71
Abrasion
62
62
Limb Fracture
40
40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Insufficient Information
32
32
Death
26
26
Pain
22
22
No Consequences Or Impact To Patient
19
19
Head Injury
19
19
Concussion
17
17
Multiple Fractures
16
16
Hip Fracture
13
13
Pressure Sores
13
13
No Code Available
11
11
Fracture, Arm
9
9
Burn(s)
9
9
No Information
9
9
Contusion
7
7
Sprain
7
7
Damage to Ligament(s)
7
7
Tooth Fracture
7
7
Joint Dislocation
6
6
Unspecified Infection
6
6
Swelling
5
5
Discomfort
5
5
Neck Pain
5
5
Patient Problem/Medical Problem
5
5
Suture Abrasion
5
5
Skin Tears
5
5
Unspecified Tissue Injury
5
5
Vertebral Fracture
5
5
Full thickness (Third Degree) Burn
4
4
Muscle/Tendon Damage
4
4
Physical Entrapment
4
4
Tissue Breakdown
3
3
Vertigo
3
3
Brain Injury
3
3
Hematoma
3
3
Crushing Injury
3
3
Eye Injury
3
3
Headache
3
3
Cellulitis
3
3
Swelling/ Edema
3
3
Easy Bruising
3
3
Inflammation
2
2
Sepsis
2
2
Rupture
2
2
Skull Fracture
2
2
Loss of consciousness
2
2
No Patient Involvement
2
2
Confusion/ Disorientation
2
2
Depression
2
2
Spinal Cord Injury
2
2
Post Traumatic Wound Infection
1
1
Needle Stick/Puncture
1
1
Complaint, Ill-Defined
1
1
Coma
1
1
Non-union Bone Fracture
1
1
Anxiety
1
1
Distress
1
1
Electric Shock
1
1
Ambulation Difficulties
1
1
Bowel Perforation
1
1
Nervous System Injury
1
1
Partial thickness (Second Degree) Burn
1
1
Cancer
1
1
Unspecified Eye / Vision Problem
1
1
Retroperitoneal Hemorrhage
1
1
Myalgia
1
1
Ulcer
1
1
Skin Discoloration
1
1
Hemorrhage/Bleeding
1
1
Hypersensitivity/Allergic reaction
1
1
Wound Dehiscence
1
1
Dehydration
1
1
Embolus
1
1
Pulmonary Emphysema
1
1
Hearing Impairment
1
1
Unspecified Musculoskeletal problem
1
1
Blister
1
1
Not Applicable
1
1
Subluxation
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
Permobil, Ab
II
Sep-15-2018
6
Sunrise Medical (US) LLC
II
May-11-2020
-
-