Definition: Intended For Medical Purposes To Move A Person With Impaired Mobility Up And Down A Stairway.
| Device Type ID | 5238 |
| Device Name | Powered Stairway Chair Lift |
| Physical State | A Motorized Lift Equipped With A Seat And Permanently Mounted In One Location On A Stairway |
| Technical Method | A Powered Patient Stairway Chair Lift Is A Motorized Lift Equipped With A Seat And Permanently Mounted In One Location That Is Intended For Medical Purposes To Move A Person With Impaired Mobility Up And Down A Stairway. |
| Target Area | N/a |
| Regulation Description | Powered Patient Transport. |
| 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) Exempt |
| CFR Regulation Number | 890.5150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5238 |
| Device | Powered Stairway Chair Lift |
| Product Code | PCD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Patient Transport. |
| CFR Regulation Number | 890.5150 [🔎] |
| Device Problems | |
|---|---|
Use Of Device Problem | 23 |
Improper Or Incorrect Procedure Or Method | 15 |
Device Handling Problem | 7 |
Device Operates Differently Than Expected | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Installation-Related Problem | 4 |
Break | 4 |
Insufficient Information | 3 |
Failure To Auto Stop | 3 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Device Component Or Accessory | 2 |
Patient-Device Incompatibility | 2 |
Defective Component | 2 |
Material Integrity Problem | 2 |
Inadequate User Interface | 2 |
Crack | 2 |
Protective Measures Problem | 2 |
Device Maintenance Issue | 2 |
Unintended Movement | 1 |
Fuse | 1 |
Misassembly By Users | 1 |
Material Fragmentation | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Overheating Of Device | 1 |
Failure To Shut Off | 1 |
Material Distortion | 1 |
Mechanics Altered | 1 |
Fail-Safe Did Not Operate | 1 |
Solder Joint Fracture | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Misassembled During Installation | 1 |
Device Reprocessing Problem | 1 |
Fracture | 1 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Component Misassembled | 1 |
Device Remains Activated | 1 |
Fail-Safe Problem | 1 |
| Total Device Problems | 110 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Acorn Stairlifts Inc | II | Apr-20-2016 |
| 2 | Savaria Concord Lifts, Inc. | II | May-10-2017 |