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U.S. Department of Health and Human Services

Product Classification

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Device electromechanical arm for a transcranial magnetic stimulation system
Regulation Description Repetitive transcranial magnetic stimulation system.
Definition To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.
Physical State A mechanical or electromechanical arm with or without a cart, a tracking system, software, 3D camera, coil adoption kit with or without its mechanical adaptor and a contact sensor.
Technical Method A tracking system measures the position and orientation of the patient’s head and the software uses the measurements provided by the tracking system to move the robotic arm and position the coil. A contact sensor allows the software to measure amount of contact applied by the coil onto the head to prevent unexpected collisions.
Target Area Head
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQFF
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5805
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible