DeviceClearance

Product code OBP— Neurology

Apollo TMS Therapy System

Classification name
Transcranial Magnetic Stimulator
Device class
Class 2
Regulation
21 CFR 882.5805
Advisory panel
Neurology
Total cleared
69
First cleared
Most recent

FDA classification definition

“A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.”

— U.S. Food and Drug Administration, device classification record for product code OBP under 21 CFR 882.5805, via openFDA

Market context for product code OBP

FDA has cleared 69 devices under product code OBP between 2008 and 2026, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OBP

Adverse 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 →

Recent clearances under product code OBP

Data sourced from openFDA. This site is unofficial and independent of the FDA.