Device and clearance claims

A clinic may say that a device is FDA cleared for a use. Trace the claim to the primary record before you rely on it.

A clearance belongs to a named system

An FDA record names a specific system, an indication and a label. It does not cover every coil, protocol or patient group. When a clinic uses the word TMS, that does not show that it offers the system in the record.

Examples from this site's guides, which checked these FDA records on 29 October 2026:

• On 17 August 2018 the FDA permitted marketing of the BrainsWay Deep Transcranial Magnetic Stimulation System for OCD. The announcement describes that specific system.
• FDA record K200957, for the BrainsWay Deep TMS System, gives an original clearance date of 21 August 2020. The record describes use as an aid in short-term smoking cessation in adults. An administrative letter dated 2 June 2021 changed the product code and states that the submission was not reviewed again. It is not a new indication.
• FDA record K220177, dated 1 September 2022, is for the Magnus Neuromodulation System with SAINT Technology. It does not apply to every clinic that uses the word accelerated.

These dates concern specific devices. They are not a ranking of protocols.

Questions to ask

• Which exact device and protocol do you propose?
• Does the proposed use follow the current device label?
• If not, can the clinician explain the use outside the label, the alternatives and the consent process?

What a clearance does not prove

A clearance does not promise a result for a person. A US clearance does not establish funding or authorization in Canada, the UK or Australia. In the US, an insurer can also use its own coverage rules.

Sources

• TMSClinics guide, TMS protocols explained, updated 29 October 2026
• TMSClinics guide, TMS for OCD and smoking cessation, updated 29 October 2026
• FDA, BrainsWay Deep TMS System, K200957, fetched 29 October 2026
• FDA, Magnus Neuromodulation System with SAINT Technology, K220177, fetched 29 October 2026
• FDA press announcement on TMS for OCD, 17 August 2018, fetched 29 October 2026

This course is general information, not medical, legal or financial advice.