Cleared Traditional

Ultimate rTMS; Yingchi rTMS

K230735 · Brain Ultimate, Inc. · Neurology
Sep 2023
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K230735 is an FDA 510(k) clearance for the Ultimate rTMS; Yingchi rTMS, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Brain Ultimate, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 13, 2023, 181 days after receiving the submission on March 16, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K230735 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2023
Decision Date September 13, 2023
Days to Decision 181 days
Submission Type Traditional
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.