MRI — Orthosis, Truncal/Orthosis, Limb Class I
FDA product code MRI covers "Orthosis, Truncal/Orthosis, Limb", a Class I medical device regulated under 21 CFR 890.3490. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MRI
- Device Class
- Class I
- Regulation Number
- 890.3490
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No