| Device Type ID | 5132 |
| Device Name | Wheelchair, Mechanical |
| Regulation Description | Mechanical Wheelchair. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.3850 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IOR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5132 |
| Device | Wheelchair, Mechanical |
| Product Code | IOR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mechanical Wheelchair. |
| CFR Regulation Number | 890.3850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CONVAID PRODUCTS LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANYANG SUNTEC AUTO PARTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FREE WHEELCHAIR MISSION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FREEDOM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARRIS MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INVACARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
INVACARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
MOTION COMPOSITES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PDG PRODUCT DESIGN GROUP INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PDG PRODUCT DESIGN GROUP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROACTIVE COMFORT, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
R82 A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RUPIANI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUNRISE MEDICAL (US) LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VALENTINE INTL. LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WINNER SG PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZHEJIANG JIAFENG ELECTRICAL & MECHANIAL CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 351 |
Unstable | 127 |
Bent | 97 |
Frame | 75 |
Detachment Of Device Component | 44 |
Torn Material | 43 |
Crack | 40 |
Product Quality Problem | 39 |
Device Operates Differently Than Expected | 37 |
Mechanical Problem | 32 |
Out-Of-Box Failure | 32 |
Wheel | 30 |
Weld | 23 |
Unintended Movement | 21 |
Adverse Event Without Identified Device Or Use Problem | 18 |
Unraveled Material | 15 |
Device Inoperable | 12 |
Device Slipped | 12 |
Naturally Worn | 12 |
Caster | 9 |
Material Frayed | 8 |
Component Missing | 7 |
Insufficient Information | 7 |
Detachment Of Device Or Device Component | 6 |
Scratched Material | 6 |
Device Subassembly | 6 |
Material Separation | 6 |
Hole In Material | 6 |
Bolt | 6 |
Brake | 5 |
Wheelchair, Wheels | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Material Integrity Problem | 5 |
Use Of Device Problem | 5 |
Mechanical Jam | 5 |
Inadequacy Of Device Shape And/or Size | 5 |
Mechanics Altered | 5 |
Collapse | 5 |
Noise, Audible | 4 |
Device Damaged Prior To Use | 4 |
Rail | 4 |
Fracture | 3 |
Cable | 3 |
Appropriate Term/Code Not Available | 3 |
Device Tipped Over | 3 |
Deformation Due To Compressive Stress | 3 |
Screw | 2 |
Bearings | 2 |
Loss Of Or Failure To Bond | 2 |
Joystick | 2 |
Patient-Device Incompatibility | 2 |
Handpiece | 2 |
Lock | 2 |
Pin | 2 |
Positioning Problem | 2 |
Housing | 2 |
Component Falling | 2 |
Loose Or Intermittent Connection | 2 |
Thread | 2 |
Spacer | 2 |
Failure To Align | 2 |
Unintended Collision | 2 |
Material Deformation | 2 |
Cover | 2 |
Tube | 2 |
Plate | 1 |
Device Emits Odor | 1 |
Inadequate Or Insufficient Training | 1 |
Human Factors Issue | 1 |
Installation-Related Problem | 1 |
Protective Measures Problem | 1 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
Charger | 1 |
Ball | 1 |
Device Maintenance Issue | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Defective Device | 1 |
Bolus Mechanism Failure | 1 |
Gears | 1 |
Side Rail | 1 |
Hub | 1 |
Disconnection | 1 |
Device Markings / Labelling Problem | 1 |
Misassembly During Maintenance / Repair | 1 |
Corroded | 1 |
Battery | 1 |
Extender | 1 |
Defective Component | 1 |
Compatibility Problem | 1 |
Vibration | 1 |
Human-Device Interface Problem | 1 |
Wheelchair, Tires | 1 |
Latch | 1 |
Misassembled | 1 |
Device Displays Incorrect Message | 1 |
Unintended Ejection | 1 |
Smoking | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
| Total Device Problems | 1272 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Invacare Corporation | II | Jan-08-2014 |
| 2 | Karman Healthcare Inc | II | Feb-27-2016 |
| 3 | Pdg Product Design Group Inc | II | Sep-24-2014 |
| 4 | Silver Star Brands | II | Nov-14-2014 |
| 5 | Snug Seat Inc | II | Dec-16-2014 |
| 6 | Sunrise Medical (US) LLC | II | Jul-25-2016 |
| 7 | Sunrise Medical (US) LLC | II | Aug-26-2015 |
| 8 | Sunrise Medical (US) LLC | II | Jan-27-2015 |