21 CFR 882.5805 — Transcranial Magnetic Stimulator
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5805
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 2 | 64 | SaMD |
| QFF | Electromechanical Arm For A Transcranial Magnetic Stimulation System | 2 | 1 | SaMD |
Special Controls
OBP — Transcranial Magnetic Stimulator
*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.
eCFR
OBP — Transcranial Magnetic Stimulator
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.
Ecfr Llm
QFF — Electromechanical Arm For A Transcranial Magnetic Stimulation System
*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.
eCFR
