Helmet, Cranial, For Protective Use
The Helmet, Cranial, For Protective Use (product code NDA) is a physical medicine device designed to protect the skull and brain from injury, typically used in patients who have undergone craniectomy or who are at risk of head trauma. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification requirements. It falls within the Physical Medicine specialty. The device is not flagged as an implant or life-sustaining device.
Research product code NDA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NDA
- Device Class
- FDA class 1
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.