QFF — Electromechanical Arm For A Transcranial Magnetic Stimulation System Class II
FDA product code QFF covers "Electromechanical Arm For A Transcranial Magnetic Stimulation System", a Class II medical device regulated under 21 CFR 882.5805. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFF
- Device Class
- Class II
- Regulation Number
- 882.5805
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.