QFF · Electromechanical Arm For A Transcranial Magnetic Stimulation System
Neurology · 21 CFR 882.5805 · Class 2
Overview
| Product Code | QFF |
|---|---|
| Device Name | Electromechanical Arm For A Transcranial Magnetic Stimulation System |
| Regulation | 21 CFR 882.5805 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
Classification Rationale
Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182768 | TMS-Cobot TS MV | Axilum Robotics | Feb 17, 2019 | SESE |
Top Applicants
- Axilum Robotics — 1 clearance
