| Device Type ID | 5099 |
| Device Name | Cushion, Wheelchair |
| Regulation Description | Wheelchair Component. |
| 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 | 890.3920 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IMP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5099 |
| Device | Cushion, Wheelchair |
| Product Code | IMP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Wheelchair Component. |
| CFR Regulation Number | 890.3920 [🔎] |
| Device Problems | |
|---|---|
Break | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bock,Otto,Orthopedic Ind,Inc | II | Mar-21-2014 |