| Device Type ID | 3742 |
| Device Name | Orthosis, Cranial |
| Regulation Description | Cranial Orthosis. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5970 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MVA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3742 |
| Device | Orthosis, Cranial |
| Product Code | MVA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cranial Orthosis. |
| CFR Regulation Number | 882.5970 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ORTHOMERICA PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
P-POD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Failure To Auto Stop | 1 |
| Total Device Problems | 3 |