QFF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electromechanical Arm For A Transcranial Magnetic Stimulation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5805
- Medical specialty
- Neurology
- FDA definition
- To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
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| Record | Firm | Date |
|---|---|---|
| Zeta TMS Navigation System (K261471) | Zeta Surgical, Inc. | 2026-07-09 |
| TMS-Cobot TS MV (K182768) | Axilum Robotics | 2019-02-17 |
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