FDA product code QFF: Electromechanical Arm For A Transcranial Magnetic Stimulation System
QFF is the FDA product code for electromechanical arm for a transcranial magnetic stimulation system. It is a Class II device, regulated under 21 CFR 882.5805 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under QFF, 1 in the last five years, from 2 different applicants. The average 510(k) review took 104 days (median 104); 66 days on average over the last three years.
Definition
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
Classification
| Field | Value |
|---|---|
| Device name | Electromechanical Arm For A Transcranial Magnetic Stimulation System |
| Device class | Class II |
| Regulation | 21 CFR 882.5805 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QFF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 142 |
| 2026 | 1 | 66 |
Compare with all 510(k) review times · Search every QFF clearance
Top QFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeta Surgical, Inc. | 1 | 2026-07-09 |
| Axilum Robotics | 1 | 2019-02-17 |
Most recent QFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261471 | Zeta Surgical, Inc. | Zeta TMS Navigation System | 2026-07-09 | 66 |
| K182768 | Axilum Robotics | TMS-Cobot TS MV | 2019-02-17 | 142 |
Recalls for QFF devices
openFDA lists no recalls for product code QFF.
Frequently asked questions
What is FDA product code QFF?
QFF is the FDA product code for electromechanical arm for a transcranial magnetic stimulation system. It is a Class II device, regulated under 21 CFR 882.5805 and reviewed by the Neurology panel.
What device class is QFF?
Class II, regulation 21 CFR 882.5805. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFF?
Across 2 cleared submissions the average was 104 days from receipt to decision (median 104).
Which companies have the most QFF clearances?
Zeta Surgical, Inc. (1); Axilum Robotics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QFF
- Run a recall and safety report across every QFF manufacturer
- Watch product code QFF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times