DeviceClearance

Product code QFF— Neurology

TMS-Cobot TS MV

Classification name
Electromechanical Arm For A Transcranial Magnetic Stimulation System
Device class
Class 2
Regulation
21 CFR 882.5805
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

“To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.”

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

Market context for product code QFF

FDA has cleared 2 devices under product code QFF between 2019 and 2026, filed by 2 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 QFF

Recent clearances under product code QFF

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