KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
FDA 510(k) K260396 · Fidelity BioPharma Co.
510(k) numberK260396
Submission
- Device name
- KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
- Applicant
- Fidelity BioPharma Co.
New Haven, CT, US - Received
- February 6, 2026
- Decision date
- September 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBP – Transcranial Magnetic Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5805
- Specialty
- Neurology
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.
Other 510(k)s with product code OBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260691 | BTL-699OBP · Traditional | BTL Industries, Inc. | 08/23/2026SE |
| K261228 | QuickVision Ultimate rTMSOBP · Traditional | Brain Ultimate, Inc. | 08/14/2026SE |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy SystemOBP · Traditional | Mag & More GmbH | 05/22/2026SE |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional | Tonica Elektronik A/S | 05/22/2026SE |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K251653 | SPRY TMS Therapy System (0550)OBP · Traditional | Soterix Medical, Inc. | 02/20/2026SE |
| K251391 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 11/07/2025SE |
| K250689 | CloudTMS EdgeOBP · Traditional | Teleemg, LLC | 09/14/2025SE |
| K251449 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 09/13/2025SE |
Questions and answers
When was KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) cleared by the FDA?
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) (K260396) received a 510(k) decision of Substantially Equivalent on September 6, 2026, 212 days after the submission was received.
What is the product code of K260396?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.