Product code

QFF: Electromechanical arm for a transcranial magnetic stimulation system

FDA product code · Class II · Neurology

Key facts

Product code QFF
Device Electromechanical arm for a transcranial magnetic stimulation system
Device class Class II
Regulation number 882.5805
Review panel Neurology
Medical specialty Neurology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.

At a glance

  • 1–9 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 1–9 UDI devices (GUDID)
  • None MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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