BTL-99-OC
FDA 510(k) K230657 · BTL Industries, Inc.
510(k) numberK230657
Submission
- Device name
- BTL-99-OC
- Applicant
- BTL Industries, Inc.
Marlborough, MA, US - Received
- March 9, 2023
- Decision date
- February 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5802
- Specialty
- Neurology
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Other 510(k)s with product code QCI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series)QCI · Traditional | Brain Ultimate, Inc. | 04/17/2025SE |
| K233742 | CloudTMS Edge for OCDQCI · Special | Teleemg, LLC | 12/22/2023SE |
| K231350 | OCD MT Cap (85-00397-000)QCI · Special | Neuronetics | 06/08/2023SE |
| K221129 | CloudTMS for OCDQCI · Traditional | Teleemg, LLC | 03/10/2023SE |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…QCI · Traditional | Neuronetics, Inc. | 05/06/2022SE |
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy systemQCI · Traditional | Tonica Elektronik A/S | 08/09/2020SE |
| K183303 | Brainsway Deep TMS SystemQCI · Traditional | Brainsway , Ltd. | 03/08/2019SE |
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| K252561 | BTL-754FFGEX · Traditional | 02/18/2026SE |
| K250309 | BTL-199QPL · Traditional | 08/07/2025SE |
| K243290 | BTL-785MJNUW · Traditional | 05/09/2025SE |
| K241516 | BTL-398KPI · Traditional | 02/10/2025SE |
| K241270 | BTL-754GEX · Traditional | 01/30/2025SE |
| K242532 | BTL-785BNF-ENFO · Traditional | 12/13/2024SE |
| K240234 | BTL-899MSIPF · Traditional | 08/17/2024SE |
Questions and answers
When was BTL-99-OC cleared by the FDA?
BTL-99-OC (K230657) received a 510(k) decision of Substantially Equivalent on February 1, 2024, 329 days after the submission was received.
What is the product code of K230657?
The FDA product code is QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, a Class II (moderate risk) device regulated under 21 CFR 882.5802.