FDA product code QMD: Transcranial Magnetic Stimulation System For Smoking Cessation
QMD is the FDA product code for transcranial magnetic stimulation system for smoking cessation. It is a Class II device, regulated under 21 CFR 882.5802 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under QMD. The average 510(k) review took 130 days (median 130).
Definition
Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
Classification
| Field | Value |
|---|---|
| Device name | Transcranial Magnetic Stimulation System For Smoking Cessation |
| Device class | Class II |
| Regulation | 21 CFR 882.5802 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QMD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 134 |
| 2021 | 1 | 127 |
Top QMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brainsway , Ltd. | 2 | 2021-04-16 |
Most recent QMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203616 | Brainsway , Ltd. | Brainsway Deep (DTMS) System | 2021-04-16 | 127 |
| K200957 | Brainsway , Ltd. | Brainsway Deep TMS System | 2020-08-21 | 134 |
Recalls for QMD devices
openFDA lists no recalls for product code QMD.
Frequently asked questions
What is FDA product code QMD?
QMD is the FDA product code for transcranial magnetic stimulation system for smoking cessation. It is a Class II device, regulated under 21 CFR 882.5802 and reviewed by the Neurology panel.
What device class is QMD?
Class II, regulation 21 CFR 882.5802. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMD?
Across 2 cleared submissions the average was 130 days from receipt to decision (median 130).
Which companies have the most QMD clearances?
Brainsway , Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QMD
- Run a recall and safety report across every QMD manufacturer
- Watch product code QMD 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.