Device Type ID | 2606 |
Device Name | Device, Patient Transfer, Powered |
Regulation Description | Powered 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 | 880.6775 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FRZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2606 |
Device | Device, Patient Transfer, Powered |
Product Code | FRZ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Powered Patient Transfer Device. |
CFR Regulation Number | 880.6775 [🔎] |
Device Problems | |
---|---|
Insufficient Information | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 2 |