KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)— 510(k) K260396

Name: FDA 510(k) clearance K260396
Creator: U.S. Food and Drug Administration
Published: 2026-09-06

Substantially Equivalent

Fidelity BioPharma Co.

FDA 510(k) clearance K260396 for KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A), Substantially Equivalent on 2026-09-06. Applicant: Fidelity BioPharma Co.. Device class: 2.

Clearance details

Applicant: Fidelity BioPharma Co.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2026-02-06
Decision date: 2026-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBP

view all

K260691 — BTL-6992026-08-23
K261228 — QuickVision Ultimate rTMS2026-08-14
K260189 — MagVenture Accelerated TMS (aTMS) Therapy System2026-05-22
K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System2026-05-22
K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)2026-03-20

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.