Apollo TMS Therapy System; Apollo light TMS Therapy System— 510(k) K260560
Substantially EquivalentMag & More GmbH
FDA 510(k) clearance K260560 for Apollo TMS Therapy System; Apollo light TMS Therapy System, Substantially Equivalent on 2026-05-22. Applicant: Mag & More GmbH. Device class: 2.
Summary
Mag & More's record covers two items, the Apollo TMS Therapy System and the Apollo light TMS Therapy System. The record lists one product code for both: OBP, transcranial magnetic stimulators.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel. It was a Traditional 510(k).
Mag & More filed from Munich, Germany. Review took 92 calendar days (February 19 to May 22, 2026).
Clearance details
- Device name as filed
- Apollo TMS Therapy System;Apollo light TMS Therapy System
- Applicant
- Mag & More GmbH
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code OBP
view allMore clearances from Mag & More GmbH
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.