Home › Device types › IOR
Wheelchair, Mechanical
FDA product code IOR · Class 1 · Physical Medicine
1,813
Registered devices
26,370
Adverse events
40
Recalls
463
510(k) clearances
Devices with this code
Drive — Drive Devilbiss HealthcareCARDINAL HEALTH — Cardinal Health 200, LLCDALTON MANUAL WHEELCHAIR — DALTON MEDICAL CORPORATIONDrive — Drive Devilbiss HealthcareInvacare® Wanderlust K3 Wheelchair — INVACARE CORPORATIONDALTON MANUAL WHEELCHAIR — DALTON MEDICAL CORPORATIONGuardian — MEDLINE INDUSTRIES, INC.GENDRON — GF HEALTH PRODUCTS, INC.DRIVEMEDICAL — Drive Devilbiss HealthcareZippie® Series Manual Wheelchair — SUNRISE MEDICAL (US) LLCDrive — Drive Devilbiss HealthcareDrive — Drive Devilbiss HealthcareGuardian — MEDLINE INDUSTRIES, INC.GENDRON — GF HEALTH PRODUCTS, INC.Invacare Tracer IV Wheelchair — INVACARE CORPORATIONGENDRON — GF HEALTH PRODUCTS, INC.DRIVEMEDICAL — Drive Devilbiss HealthcareDALTON WIDE MANUAL WHEELCHAIR — DALTON MEDICAL CORPORATIONAeroFly Wheelchair, 18”, Gray, SF — Drive Devilbiss HealthcareDrive — Drive Devilbiss HealthcareGENDRON — GF HEALTH PRODUCTS, INC.DRIVEMEDICAL — Drive Devilbiss HealthcareDrive — Drive Devilbiss HealthcareDrive — Drive Devilbiss Healthcare
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-24 | TiSport, Llc | Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perfor |
| 2018-09-11 | TiSport, Llc | The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. |
| 2016-07-01 | Sunrise Medical (US) LLC | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the brack |
| 2016-01-27 | Karman Healthcare Inc | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork bra |
| 2015-07-27 | Sunrise Medical (US) LLC | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occu |
| 2015-07-27 | Sunrise Medical (US) LLC | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occu |
| 2014-12-19 | Sunrise Medical (US) LLC | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| 2014-12-19 | Sunrise Medical (US) LLC | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| 2014-10-10 | Silver Star Brands | Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in da |
| 2013-11-11 | Sunrise Medical (US) LLC | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislo |
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