| Device Type ID | 5221 |
| Device Name | Orthosis, Moldable, Supportive, Skin Protective |
| Regulation Description | Limb Orthosis. |
| 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 | 890.3475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MNE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5221 |
| Device | Orthosis, Moldable, Supportive, Skin Protective |
| Product Code | MNE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Limb Orthosis. |
| CFR Regulation Number | 890.3475 [🔎] |