| Device Type ID | 2613 |
| Device Name | Mattress, Flotation Therapy, Non-powered |
| Regulation Description | Nonpowered Flotation Therapy Mattress. |
| 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 | 880.5150 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IKY |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2613 |
| Device | Mattress, Flotation Therapy, Non-powered |
| Product Code | IKY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered Flotation Therapy Mattress. |
| CFR Regulation Number | 880.5150 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 59 |
Break | 53 |
Fracture | 52 |
Use Of Device Problem | 51 |
Maintenance Does Not Comply To Manufacturers Recommendations | 47 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Degraded | 5 |
Delamination | 5 |
Decrease In Pressure | 4 |
Installation-Related Problem | 3 |
Structural Problem | 3 |
Inflation Problem | 3 |
Device Operates Differently Than Expected | 2 |
Defective Component | 2 |
Leak / Splash | 2 |
Device Slipped | 2 |
Insufficient Information | 1 |
Fluid Leak | 1 |
Material Deformation | 1 |
Air Leak | 1 |
Material Separation | 1 |
Material Discolored | 1 |
| Total Device Problems | 306 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arjo Hospital Equipment AB | II | Mar-06-2015 |
| 2 | Joerns Healthcare | II | May-30-2018 |