DeviceClearance

Product code OKP— Neurology

SpringTMS

Classification name
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Device class
Class 2
Regulation
21 CFR 882.5808
Advisory panel
Neurology
Total cleared
6
First cleared
Most recent

FDA classification definition

“Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.”

— U.S. Food and Drug Administration, device classification record for product code OKP under 21 CFR 882.5808, via openFDA

Market context for product code OKP

FDA has cleared 6 devices under product code OKP between 2013 and 2023, filed by 3 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

Top applicants under product code OKP

Recent clearances under product code OKP

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