Device Type ID | 2557 |
Device Name | Device, Transfer, Patient, Manual |
Regulation Description | Manual Patient Transfer Device. |
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 | 880.6785 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FMR |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2557 |
Device | Device, Transfer, Patient, Manual |
Product Code | FMR |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Patient Transfer Device. |
CFR Regulation Number | 880.6785 [🔎] |
Device Problems | |
---|---|
Off-Label Use | 8 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Fail-Safe Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Fracture | 1 |
Inflation Problem | 1 |
Device Operates Differently Than Expected | 1 |
Installation-Related Problem | 1 |
Device Handling Problem | 1 |
Break | 1 |
Mechanical Problem | 1 |
Total Device Problems | 19 |