Device Type ID | 2600 |
Device Name | Chair, Examination And Treatment |
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 | FRK |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2600 |
Device | Chair, Examination And Treatment |
Product Code | FRK |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Medical Chair And Table. |
CFR Regulation Number | 880.6140 [🔎] |
Device Problems | |
---|---|
Break | 4 |
Bent | 3 |
Unintended System Motion | 2 |
Device Subassembly | 2 |
Unintended Movement | 1 |
Wheel | 1 |
Detachment Of Device Or Device Component | 1 |
Caster | 1 |
Device Component Or Accessory | 1 |
Total Device Problems | 16 |