| Device Type ID | 5131 |
| Device Name | Bed, Flotation Therapy, Powered |
| Regulation Description | Powered Flotation Therapy 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 | 890.5170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IOQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5131 |
| Device | Bed, Flotation Therapy, Powered |
| Product Code | IOQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Flotation Therapy Bed. |
| CFR Regulation Number | 890.5170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HILL-ROM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HILL-ROM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 3 |
Therapeutic Or Diagnostic Output Failure | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Electrical /Electronic Property Problem | 1 |
Connection Problem | 1 |
Blower | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operational Issue | 1 |
Detachment Of Device Component | 1 |
Device Maintenance Issue | 1 |
Pressure Problem | 1 |
Use Of Incorrect Control Settings | 1 |
Installation-Related Problem | 1 |
Device Handling Problem | 1 |
Insufficient Information | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Medical Division Of Stryker Corporation | II | Sep-15-2018 |