| Device Type ID | 5122 |
| Device Name | Bed, Air Fluidized |
| Regulation Description | Air-fluidized Bed. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5160 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | INX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5122 |
| Device | Bed, Air Fluidized |
| Product Code | INX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Air-fluidized Bed. |
| CFR Regulation Number | 890.5160 [🔎] |
| Device Problems | |
|---|---|
Device Inoperable | 9 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Use Of Device Problem | 6 |
Insufficient Information | 4 |
Pressure Problem | 2 |
Unintended Movement | 2 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Air Leak | 1 |
Device Issue | 1 |
Break | 1 |
Collapse | 1 |
Mechanical Problem | 1 |
Defective Device | 1 |
Improper Flow Or Infusion | 1 |
Temperature Problem | 1 |
Torn Material | 1 |
Device Alarm System | 1 |
Component Falling | 1 |
Device Displays Incorrect Message | 1 |
Defective Component | 1 |
Fire | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 49 |