510(k) clearance

KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

FDA 510(k) source

510(k) number

K260396

Applicant

Fidelity BioPharma Co.

Decision date

Sep 6, 2026

Date received

Feb 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OBP

Device type

Transcranial Magnetic Stimulator

Device class

Class II

Regulation

21 CFR 882.5805

Advisory committee

Neurology

Statement or summary

Summary

Third party

N

Location

New Haven, CT, US