| Device Type ID | 2562 |
| Device Name | Lift, Patient, Ac-powered |
| Regulation Description | AC-powered Patient Lift. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FNG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2562 |
| Device | Lift, Patient, Ac-powered |
| Product Code | FNG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AC-powered Patient Lift. |
| CFR Regulation Number | 880.5500 [🔎] |
| Device Problems | |
|---|---|
Use Of Device Problem | 11 |
Device Handling Problem | 10 |
Detachment Of Device Or Device Component | 10 |
Detachment Of Device Component | 9 |
Inadequate Or Insufficient Training | 8 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Device Tipped Over | 7 |
Break | 6 |
Component Falling | 3 |
Labelling, Instructions For Use Or Training Problem | 2 |
Insufficient Information | 2 |
Electrical /Electronic Property Problem | 2 |
Corroded | 2 |
Misconnection | 1 |
Device Inoperable | 1 |
Unstable | 1 |
Solder Joint Fracture | 1 |
Bent | 1 |
Device Operates Differently Than Expected | 1 |
Screw | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Split | 1 |
Crack | 1 |
Positioning Problem | 1 |
Connector Pin | 1 |
Human Factors Issue | 1 |
Misassembly By Users | 1 |
Clip | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Unintended Movement | 1 |
| Total Device Problems | 98 |