KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)— 510(k) K260396
Substantially EquivalentFidelity 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.
Summary
Fidelity BioPharma's KCS rTMS Therapy System is cleared in two models, MetaStim 100 and MetaStim 100A. Product code OBP is transcranial magnetic stimulators. The record doesn't say how the two models differ, and it gives no indications.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Fidelity BioPharma filed from New Haven, Connecticut. The decision came 212 calendar days after receipt (February 6 to September 6, 2026).
Clearance details
- Applicant
- Fidelity BioPharma Co.
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Haven, CT, US
Recent devices under product code OBP
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . 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.