Device Type ID | 2599 |
Device Name | Chair, Geriatric |
Regulation Description | Medical Chair And Table. |
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 | 880.6140 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FRJ |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2599 |
Device | Chair, Geriatric |
Product Code | FRJ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Medical Chair And Table. |
CFR Regulation Number | 880.6140 [🔎] |
Device Problems | |
---|---|
Unstable | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Use Of Device Problem | 1 |
Device Tipped Over | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Sensing Problem | 1 |
Failure To Sense | 1 |
Device Alarm System | 1 |
Break | 1 |
Total Device Problems | 11 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Hill-Rom, Inc. | II | Feb-23-2016 |