Electromechanical Arm For A Transcranial Magnetic Stimulation System

QFF · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5805

Classification

FDA Product Code: QFF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5805
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 1
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown