Device Type ID | 5225 |
Device Name | Helmet, Cranial, For Protective Use |
Regulation Description | Prosthetic And Orthotic Accessory. |
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 | 890.3025 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NDA |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5225 |
Device | Helmet, Cranial, For Protective Use |
Product Code | NDA |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Prosthetic And Orthotic Accessory. |
CFR Regulation Number | 890.3025 [🔎] |