Cleared Special

T65 (9016E061-)

K252032 · Tonica Elektronik A/S · Neurology

Jul 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K252032 is an FDA 510(k) clearance for the T65 (9016E061-), a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on July 30, 2025, 30 days after receiving the submission on June 30, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K252032 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	July 30, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OBP — Transcranial Magnetic Stimulator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5805
Definition	A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.