| Device Type ID | 5204 |
| Device Name | Cushion, Flotation |
| Regulation Description | Flotation Cushion. |
| 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 | 890.3175 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KIC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5204 |
| Device | Cushion, Flotation |
| Product Code | KIC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Flotation Cushion. |
| CFR Regulation Number | 890.3175 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Air Leak | 3 |
Insufficient Information | 3 |
Break | 2 |
Hole In Material | 1 |
Leak / Splash | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Inadequate Storage | 1 |
Material Puncture / Hole | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 23 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roho Inc. | II | Apr-05-2017 |