Cleared Traditional

K230735 - Ultimate rTMS (FDA 510(k) Clearance)

Also includes:
Yingchi rTMS

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230735 · Brain Ultimate, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
181d
Days
Class 2
Risk

K230735 is an FDA 510(k) clearance for the Ultimate rTMS. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Brain Ultimate, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 13, 2023 after a review of 181 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Brain Ultimate, Inc. devices

Submission Details

510(k) Number K230735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 148d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Makromed, Inc.
Barry Ashar

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBP Transcranial Magnetic Stimulator

All 63
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K230735.
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · Nexstim Oyj · Mar 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · Nexstim Oyj · Mar 2026
SPRY TMS Therapy System (0550)
K251653 · Soterix Medical, Inc. · Feb 2026
BrainsWay Deep TMS System
K251391 · Brainsway , Ltd. · Nov 2025
CloudTMS Edge
K250689 · Teleemg, LLC · Sep 2025
BrainsWay Deep TMS System
K251449 · Brainsway , Ltd. · Sep 2025