510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QFFClass II

Electromechanical Arm For A Transcranial Magnetic Stimulation System

21 CFR 882.5805 / Neurology
FDA source (opens on fda.gov)

QFF is the FDA product code for Electromechanical Arm For A Transcranial Magnetic Stimulation System, a class II device type, regulated under 21 CFR 882.5805. FDA's definition for this code reads: "To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QFF
Device name
Electromechanical Arm For A Transcranial Magnetic Stimulation System
FDA definition
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
Regulation
21 CFR 882.5805
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QFF

By decision year
2 clearances under product code QFF with a decision year between 2019 and 2026, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QFF by decision year
YearClearances
20191
20261

Applicants with the most clearances

Product code QFF
Applicants holding the most 510(k) clearances under product code QFF
ApplicantClearances
Axilum Robotics1
Zeta Surgical Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code